Clinical trial NCT03888066: Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperkalemia
Keywords: treatment of hyperkalemia
chronic kidney disease
hypertension
hyperkalemia
potassium
spironolactone
heart failure
Renin Angiotensin-Aldosterone System Inhibitor (RAASi)
RAASi
high potassium
eplerenone
reduced ejection fraction
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2019-03-25
Enrollment: 1195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Phase 3b multinational, multicenter, double-blind, placebo-controlled, randomized withdrawal, parallel group study that includes screening and 12 weeks Run-in Phase and a randomized withdrawal Blinded Treatment Phase.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.

Detailed description: Prospective Phase 3b multinational, multicenter, double-blind, placebo-controlled, randomized withdrawal, parallel group study that includes screening and up to 12 weeks Run-in Phase (all subjects will have patiromer initiated and RAASi medications, including mineralocorticoid receptor antagonist (MRA) optimized) and a randomized withdrawal Blinded Treatment Phase.

The study population includes subjects with heart failure (HF) with reduced ejection fraction (HFrEF) who are hyperkalemic (serum potassium \[K+\] \> 5.0 mEq/L) while receiving treatment with renin angiotensin aldosterone system inhibitor (RAASi) medications or who are normokalemic (serum K+ 4.0 - 5.0 mEq/L) but have a history of hyperkalemia prior to screening with subsequent reduction or discontinuation of a RAASi medication.

Each subject's participation includes a Run-in Phase (maximum 12 weeks) followed by the Treatment Phase (variable per subject). Study duration for individual subjects will vary, depending on their individual enrollment date. Subjects who prematurely discontinue patiromer/placebo will remain in the study for the collection of clinical events data and will receive usual care.

Eligibility criteria: Inclusion Criteria:

* Age at least 18 years or greater
* Symptomatic low ejection fraction heart failure (weak heart muscle)
* Receiving any dose of a beta blocker for the treatment of HF (unless not able to tolerate)
* Kidney function not more than mild or moderately impaired
* High blood potassium (\>5.0 mEq/L) currently while receiving medications for heart failure OR normal blood potassium currently but previously had high potassium in the12 months prior to screening which caused a permanent reduction or discontinuation of heart failure medications
* Hospitalization for heart failure or treatment in an out patient setting with intravenous medications within the last 12 months before screening.

Exclusion Criteria:

* Current acute decompensated HF, within 4 weeks before screening. Subjects with a discharge from a hospitalization for acute decompensation of HF longer than 4 weeks before screening may be included
* Significant primary aortic or mitral valvular heart disease (except secondary mitral regurgitation due to left ventricular dilatation)
* Heart transplantation or planned heart transplantation (i.e., currently on a heart transplant waiting list) during the study period

Primary outcomes:
measure: Changes in Serum K+ Levels From Baseline
timeFrame: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo
Secondary outcomes:
measure: CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time
timeFrame: From Day 1/Baseline to week 90
measure: CIF Estimates of the Reduction of the MRA Dose Below Target Dose Over Time
timeFrame: From Day 1/Baseline to week 102
measure: Investigator-reported Events of Hyperkalemia
timeFrame: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo
measure: Hyperkalemia-related Hard Outcomes Endpoints
timeFrame: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo
measure: RAASi Use Score
timeFrame: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Investigator Site 11-080
state: Alabama
city: Huntsville
country: United States
facility: Investigator Site 11-041
state: Alabama
city: Phoenix
country: United States
facility: Investigator Site 11-153
state: Arizona
city: Tucson
country: United States
facility: Investigator Site 11-097
state: Arizona
city: Bakersfield
country: United States
facility: Investigator Site 11-052
state: California
city: Fremont
country: United States
facility: Investigator Site 11-174
state: California
city: Fresno
country: United States
facility: Investigator Site 11-136
state: California
city: Huntington Beach
country: United States
facility: Investigator Site 11-102
state: California
city: La Jolla
country: United States
facility: Investigator Site 11-162
state: California
city: La Mesa
country: United States
facility: Investigator Site 11-048
state: California
city: Laguna Hills
country: United States
facility: Investigator Site 11-111
state: California
city: Long Beach
country: United States
facility: Investigator Site 11-017
state: California
city: Northridge
country: United States
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state: California
city: Pasadena
country: United States
facility: Investigator Site 11-035
state: California
city: Sacramento
country: United States
facility: Investigator Site 11-044
state: California
city: San Diego
country: United States
facility: Investigator Site 11-135
state: California
city: San Diego
country: United States
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state: California
city: Santa Ana
country: United States
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state: California
city: Stockton
country: United States
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state: California
city: Thousand Oaks
country: United States
facility: Investigator Site 11-047
state: California
city: Van Nuys
country: United States
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state: California
city: West Hills
country: United States
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state: California
city: Aurora
country: United States
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state: Colorado
city: Altamonte Springs
country: United States
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city: Boynton Beach
country: United States
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state: Florida
city: Brandon
country: United States
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state: Florida
city: Doral
country: United States
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state: Florida
city: Gainesville
country: United States
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state: Florida
city: Greenacres City
country: United States
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state: Florida
city: Homestead
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Medley
country: United States
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state: Florida
city: Miami Lakes
country: United States
facility: Research Site 11-001
state: Florida
city: Miami Lakes
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
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country: United States
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city: North Miami Beach
country: United States
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state: Florida
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country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
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country: United States
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state: Florida
city: Pembroke Pines
country: United States
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city: Pompano Beach
country: United States
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city: Tamarac
country: United States
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state: Florida
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country: United States
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state: Florida
city: Tampa
country: United States
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state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Columbus
country: United States
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country: United States
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state: Georgia
city: Arlington Heights
country: United States
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state: Illinois
city: Hazel Crest
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state: Illinois
city: Peoria
country: United States
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state: Illinois
city: Peoria
country: United States
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state: Illinois
city: Merrillville
country: United States
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state: Indiana
city: Munster
country: United States
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state: Indiana
city: Richmond
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state: Indiana
city: Owensboro
country: United States
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state: Kentucky
city: Opelousas
country: United States
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state: Louisiana
city: West Monroe
country: United States
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state: Louisiana
city: Baltimore
country: United States
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state: Maryland
city: Columbia
country: United States
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state: Maryland
city: Boston
country: United States
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state: Massachusetts
city: Detroit
country: United States
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state: Michigan
city: Livonia
country: United States
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state: Michigan
city: Rochester
country: United States
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state: Michigan
city: Rochester
country: United States
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state: Michigan
city: Jackson
country: United States
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state: Mississippi
city: Kansas City
country: United States
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state: Missouri
city: Saint Louis
country: United States
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state: Missouri
city: Lincoln
country: United States
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state: Nebraska
city: Las Vegas
country: United States
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state: Nevada
city: North Las Vegas
country: United States
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state: Nevada
city: Haddon Heights
country: United States
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state: New Jersey
city: Linden
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country: United States
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state: New Mexico
city: Bronx
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state: New York
city: Brooklyn
country: United States
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state: New York
city: Brooklyn
country: United States
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state: New York
city: Buffalo
country: United States
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state: New York
city: Manhasset
country: United States
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state: New York
city: Richmond Hill
country: United States
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city: Staten Island
country: United States
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state: New York
city: Stony Brook
country: United States
facility: Investigator Site 11-021
state: New York
city: Charlotte
country: United States
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state: North Carolina
city: Charlotte
country: United States
facility: Investigator Site 11-075
state: North Carolina
city: Greenville
country: United States
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state: North Carolina
city: Lumberton
country: United States
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state: North Carolina
city: Columbus
country: United States
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state: Ohio
city: Lorain
country: United States
facility: Investigator Site 11-064
state: Ohio
city: Marion
country: United States
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state: Ohio
city: Toledo
country: United States
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state: Ohio
city: Bartlesville
country: United States
facility: Investigator Site 11-074
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigator Site 11-124
state: Oklahoma
city: Hillsboro
country: United States
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state: Oregon
city: Portland
country: United States
facility: Investigator Site 11-169
state: Oregon
city: Erie
country: United States
facility: Investigator Site 11-165
state: Pennsylvania
city: Hershey
country: United States
facility: Investigator Site 11-082
state: Pennsylvania
city: Greenville
country: United States
facility: Investigator Site 11-110
state: South Carolina
city: Greenwood
country: United States
facility: Investigator Site 11-098
state: South Carolina
city: Lancaster
country: United States
facility: Investigator Site 11-119
state: South Carolina
city: Rock Hill
country: United States
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state: South Carolina
city: Chattanooga
country: United States
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state: Tennessee
city: Jackson
country: United States
facility: Investigator Site 11-091
state: Tennessee
city: Memphis
country: United States
facility: Investigator Site 11-142
state: Tennessee
city: Memphis
country: United States
facility: Investigator Site 11-083
state: Tennessee
city: Tullahoma
country: United States
facility: Investigator Site 11-134
state: Tennessee
city: Allen
country: United States
facility: Investigator Site 11-104
state: Texas
city: Allen
country: United States
facility: Investigator Site 11-185
state: Texas
city: Amarillo
country: United States
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state: Texas
city: Dallas
country: United States
facility: Investigator Site 11-176
state: Texas
city: Dallas
country: United States
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state: Texas
city: Denison
country: United States
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state: Texas
city: Fort Worth
country: United States
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state: Texas
city: Gonzales
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Katy
country: United States
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state: Texas
city: Lampasas
country: United States
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state: Texas
city: McKinney
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Sugar Land
country: United States
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state: Texas
city: Webster
country: United States
facility: Investigator Site 11-160
state: Texas
city: Salt Lake City
country: United States
facility: Investigator Site 11-178
state: Utah
city: Norfolk
country: United States
facility: Investigator Site 11-158
state: Virginia
city: Norfolk
country: United States
facility: Investigator Site 11-188
state: Virginia
city: Morgantown
country: United States
facility: Investigator Site 11-065
state: West Virginia
city: Milwaukee
country: United States
facility: Investigator Site 11-045
state: Wisconsin
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Investigator Site 21-006
state: Buenos Aires
city: Ciudadela
country: Argentina
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state: Buenos Aires
city: Ramos Mejía
country: Argentina
facility: Investigator Site 21-020
state: Buenos Aires
city: San Nicolás
country: Argentina
facility: Investigator Site 21-004
state: Buenos Aires
city: Córdoba
country: Argentina
facility: Investigator Site 21-011
state: Cordoba
city: Córdoba
country: Argentina
facility: Investigator Site 21-021
state: Cordoba
city: Córdoba
country: Argentina
facility: Investigator Site 21-014
state: Cordoba
city: Villa María
country: Argentina
facility: Investigator Site 21-015
state: Cordoba
city: Mar Del Plata
country: Argentina
facility: Investigator Site 21-019
state: Provincia De Buenos Aires
city: San Miguel De Tucumán
country: Argentina
facility: Investigator Site 21-010
state: Tucuman
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Investigator Site 21-012
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Investigator Site 21-003
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Investigator Site 21-018
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Investigator Site 21-008
city: Salta
country: Argentina
facility: Investigator Site 21-017
city: San Luis
country: Argentina
facility: Investigator Site 21-005
city: Santa Fe
country: Argentina
facility: Investigator Site 21-009
city: Mechelen
country: Belgium
facility: Investigator Site 44-002
state: Antwerp
city: Ghent
country: Belgium
facility: Investigator Site 44-001
state: Oost Vlaanderen
city: Aalst
country: Belgium
facility: Investigator Site 44-005
city: Brussels
country: Belgium
facility: Investigator Site 44-009
city: Genk
country: Belgium
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city: Hasselt
country: Belgium
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city: Leuven
country: Belgium
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city: Liège
country: Belgium
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city: Roeselare
country: Belgium
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city: Yvoir
country: Belgium
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city: Salvador
country: Brazil
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state: Bahia
city: Fortaleza
country: Brazil
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state: Ceará
city: Fortaleza
country: Brazil
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city: Brasília
country: Brazil
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state: Distrito Federal
city: Vitória
country: Brazil
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state: Espirito Santo
city: Belo Horizonte
country: Brazil
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state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Investigator Site 22-005
state: Minas Gerais
city: Uberlândia
country: Brazil
facility: Investigator Site 22-004
state: Minas Gerais
city: Campina Grande Do Sul
country: Brazil
facility: Investigator Site 22-010
state: Paraná
city: Canoas
country: Brazil
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state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
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state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Investigator Site 22-003
state: RS
city: Porto Alegre
country: Brazil
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country: Brazil
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city: Porto Alegre
country: Brazil
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state: SC
city: Aracaju
country: Brazil
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state: Sergipe
city: Campinas
country: Brazil
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state: São Paulo
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country: Brazil
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city: São José Do Rio Preto
country: Brazil
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state: São Paulo
city: Rio De Janeiro
country: Brazil
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city: São Paulo
country: Brazil
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city: São Paulo
country: Brazil
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city: Burgas
country: Bulgaria
facility: Investigator Site 61-003
city: Pleven
country: Bulgaria
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city: Plovdiv
country: Bulgaria
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city: Ruse
country: Bulgaria
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city: Sofia
country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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city: Winnipeg
country: Canada
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state: Manitoba
city: Saint John's
country: Canada
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state: Newfoundland and Labrador
city: Cambridge
country: Canada
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state: Ontario
city: London
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city: Newmarket
country: Canada
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state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: Greenfield Park
country: Canada
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state: Quebec
city: Sherbrooke
country: Canada
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state: Quebec
city: Trois-Rivières
country: Canada
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state: Quebec
city: Brno
country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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city: Uherské Hradiště
country: Czechia
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city: Bordeaux
country: France
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city: La Tronche
country: France
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city: Lille
country: France
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city: Lyon
country: France
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city: Montpellier
country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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city: Rouen
country: France
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city: Saint-Brieuc
country: France
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city: Toulon
country: France
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city: Toulouse
country: France
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city: Tourcoing
country: France
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city: Valenciennes
country: France
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city: Valenciennes
country: France
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city: Batumi
country: Georgia
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city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
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city: Coburg
country: Germany
facility: Investigator Site 33-011
state: Bavarian
city: Greifswald
country: Germany
facility: Investigator Site 33-008
state: Mecklenburg-Vorpommern
city: Homburg
country: Germany
facility: Investigator Site 33-006
state: Saar
city: Bad Oeynhausen
country: Germany
facility: Investigator Site 33-023
city: Berlin
country: Germany
facility: Investigator Site 33-020
city: Berlin
country: Germany
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city: Bielefeld
country: Germany
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country: Germany
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city: Erfurt
country: Germany
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city: Essen
country: Germany
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city: Frankfurt
country: Germany
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country: Germany
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city: Gießen
country: Germany
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city: Halle
country: Germany
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city: Hamburg
country: Germany
facility: Investigator Site 33-005
city: Hanover
country: Germany
facility: Investigator Site 33-022
city: Heilbronn
country: Germany
facility: Investigator Site 33-012
city: Kiel
country: Germany
facility: Investigator Site 33-017
city: Leipzig
country: Germany
facility: Investigator Site 33-021
city: Leverkusen
country: Germany
facility: Investigator Site 33-010
city: Minden
country: Germany
facility: Investigator Site 33-024
city: Nürnberg
country: Germany
facility: Investigator Site 33-014
city: Würzburg
country: Germany
facility: Investigator Site 33-003
city: Budapest
country: Hungary
facility: Investigator Site 64-010
city: Budapest
country: Hungary
facility: Investigator Site 64-002
city: Budapest
country: Hungary
facility: Investigator Site 64-006
city: Budapest
country: Hungary
facility: Investigator Site 64-009
city: Kecskemét
country: Hungary
facility: Investigator Site 64-001
city: Kistarcsa
country: Hungary
facility: Investigator Site 64-007
city: Nyiregyhaza
country: Hungary
facility: Investigator Site 64-005
city: Ashqelon
country: Israel
facility: Investigator Site 35-008
city: Be'er Ya'aqov
country: Israel
facility: Investigator Site 35-009
city: Hadera
country: Israel
facility: Investigator Site 35-003
city: Haifa
country: Israel
facility: Investigator Site 35-006
city: Haifa
country: Israel
facility: Investigator Site 35-007
city: H̱olon
country: Israel
facility: Investigator Site 35-002
city: Jerusalem
country: Israel
facility: Investigator Site 35-005
city: Jerusalem
country: Israel
facility: Investigator Site 35-014
city: Jerusalem
country: Israel
facility: Investigator Site 35-001
city: Nahariya
country: Israel
facility: Investigator Site 35-010
city: Petah tikva
country: Israel
facility: Investigator Site 35-011
city: Ramat Gan
country: Israel
facility: Investigator Site 35-013
city: Safed
country: Israel
facility: Investigator Site 35-012
city: Tiberias
country: Israel
facility: Investigator Site 35-016
city: Ancona
country: Italy
facility: Investigator Site 34-005
city: Bergamo
country: Italy
facility: Investigator Site 34-002
city: Brescia
country: Italy
facility: Investigator Site 34-007
city: Caserta
country: Italy
facility: Investigator Site 34-001
city: Cona
country: Italy
facility: Investigator Site 34-009
city: Foggia
country: Italy
facility: Investigator Site 34-014
city: Genova
country: Italy
facility: Investigator Site 34-010
city: Milano
country: Italy
facility: Investigator Site 34-004
city: Piacenza
country: Italy
facility: Investigator Site 34-012
city: Roma
country: Italy
facility: Investigator Site 34-003
city: San Bonifacio
country: Italy
facility: Investigator Site 34-013
city: Cuauhtémoc
country: Mexico
facility: Investigator Site 23-007
state: Ciudad De Mexico
city: Delegación Gustavo A. Madero
country: Mexico
facility: Investigator Site 23-005
state: Ciudad De Mexico
city: Guadalajara
country: Mexico
facility: Investigator Site 23-012
state: Jalisco
city: Guadalajara
country: Mexico
facility: Investigator Site 23-004
state: Jalisco
city: San Pedro Garza Garcia
country: Mexico
facility: Investigator Site 23-010
state: Nuevo Léon
city: Oaxaca de Juarez
country: Mexico
facility: Investigator Site 23-011
state: Oaxaca
city: Santiago De Querétaro
country: Mexico
facility: Investigator Site 23-001
state: Querétaro
city: Culiacán
country: Mexico
facility: Investigator Site 23-002
state: Sinaloa
city: Xalapa
country: Mexico
facility: Investigator Site 23-006
state: Veracruz
city: Rotterdam
country: Netherlands
facility: Investigator Site 36-003
state: South Holland
city: 's-Hertogenbosch
country: Netherlands
facility: Investigator Site 36-002
city: Amstelveen
country: Netherlands
facility: Investigator Site 36-012
city: Blaricum
country: Netherlands
facility: Investigator Site 36-006
city: Dirksland
country: Netherlands
facility: Investigator Site 36-009
city: Dordrecht
country: Netherlands
facility: Investigator Site 36-015
city: Ede
country: Netherlands
facility: Investigator Site 36-007
city: Groningen
country: Netherlands
facility: Investigator Site 36-001
city: Helmond
country: Netherlands
facility: Investigator Site 36-013
city: Hoorn
country: Netherlands
facility: Investigator Site 36-014
city: Schiedam
country: Netherlands
facility: Investigator Site 36-010
city: Tilburg
country: Netherlands
facility: Investigator Site 36-004
city: Utrecht
country: Netherlands
facility: Investigator Site 36-011
city: Białystok
country: Poland
facility: Investigator Site 65-007
city: Katowice
country: Poland
facility: Investigator Site 65-014
city: Kędzierzyn-Koźle
country: Poland
facility: Investigator Site 65-012
city: Olsztyn
country: Poland
facility: Investigator Site 65-019
city: Ostrowiec Świętokrzyski
country: Poland
facility: Investigator Site 65-015
city: Pomorskie
country: Poland
facility: Investigator Site 65-021
city: Poznań
country: Poland
facility: Investigator Site 65-003
city: Poznań
country: Poland
facility: Investigator Site 65-020
city: Rzeszów
country: Poland
facility: Investigator Site 65-008
city: Wrocław
country: Poland
facility: Investigator Site 65-010
city: Wrocław
country: Poland
facility: Investigator Site 65-005
city: Zgierz
country: Poland
facility: Investigator Site 65-011
city: Łódź
country: Poland
facility: Investigator Site 65-001
city: Łódź
country: Poland
facility: Investigator Site 65-018
city: Izhevsk
country: Russian Federation
facility: Investigator Site 66-014
state: Udmurt Republic
city: Chelyabinsk
country: Russian Federation
facility: Investigator Site 66-008
city: Ekaterinburg
country: Russian Federation
facility: Investigator Site 66-001
city: Kazan
country: Russian Federation
facility: Investigator Site 66-016
city: Kemerovo
country: Russian Federation
facility: Investigator Site 66-010
city: Moscow
country: Russian Federation
facility: Investigator Site 66-015
city: Moscow
country: Russian Federation
facility: Investigator Site 66-004
city: Moscow
country: Russian Federation
facility: Investigator Site 66-011
city: Moscow
country: Russian Federation
facility: Investigator Site 66-017
city: Novosibirsk
country: Russian Federation
facility: Investigator Site 66-002
city: Penza
country: Russian Federation
facility: Investigator Site 66-005
city: Perm
country: Russian Federation
facility: Investigator Site 66-007
city: Petrozavodsk
country: Russian Federation
facility: Investigator Site 66-012
city: Ryazan'
country: Russian Federation
facility: Investigator Site 66-018
city: Saint Petersburg
country: Russian Federation
facility: Investigator Site 66-013
city: Saint Petersburg
country: Russian Federation
facility: Investigator Site 66-003
city: Tver
country: Russian Federation
facility: Investigator Site 66-009
city: Belgrade
country: Serbia
facility: Investigator Site 67-010
city: Belgrade
country: Serbia
facility: Investigator Site 67-002
city: Belgrade
country: Serbia
facility: Investigator Site 67-004
city: Belgrade
country: Serbia
facility: Investigator Site 67-008
city: Niška Banja
country: Serbia
facility: Investigator Site 67-007
city: Niš
country: Serbia
facility: Investigator Site 67-005
city: Sremska Kamenica
country: Serbia
facility: Investigator Site 67-001
city: Šabac
country: Serbia
facility: Investigator Site 67-003
city: Palma De Mallorca
country: Spain
facility: Investigator Site 37-014
state: Baleares
city: Castellón De La Plana
country: Spain
facility: Investigator Site 37-010
state: Castellon
city: Barcelona
country: Spain
facility: Investigator Site 37-003
state: Cataluña
city: Santiago De Compostela
country: Spain
facility: Investigator Site 37-005
state: La Coruña
city: Majadahonda
country: Spain
facility: Investigator Site 37-011
state: Madrid
city: Marbella
country: Spain
facility: Investigator Site 37-024
state: Malaga
city: La Laguna
country: Spain
facility: Investigator Site 37-016
state: Tenerife
city: Manises
country: Spain
facility: Investigator Site 37-001
state: Valencia
city: Alicante
country: Spain
facility: Investigator Site 37-012
city: Badalona
country: Spain
facility: Investigator Site 37-015
city: Barcelona
country: Spain
facility: Investigator Site 37-007
city: Barcelona
country: Spain
facility: Investigator Site 37-002
city: Huelva
country: Spain
facility: Investigator Site 37-018
city: La Coruña
country: Spain
facility: Investigator Site 37-025
city: Lleida
country: Spain
facility: Investigator Site 37-023
city: Madrid
country: Spain
facility: Investigator Site 37-004
city: Madrid
country: Spain
facility: Investigator Site 37-006
city: Madrid
country: Spain
facility: Investigator Site 37-021
city: Madrid
country: Spain
facility: Investigator Site 37-020
city: Madrid
country: Spain
facility: Investigator Site 37-026
city: Murcia
country: Spain
facility: Investigator Site 37-022
city: Málaga
country: Spain
facility: Investigator Site 37-017
city: Sevilla
country: Spain
facility: Investigator Site 37-013
city: Valencia
country: Spain
facility: Investigator Site 37-009
city: Valencia
country: Spain
facility: Investigator Site 37-008
city: Kharkiv
country: Ukraine
facility: Investigator Site 68-008
state: Novobavarskiy
city: Dnipro
country: Ukraine
facility: Investigator Site 68-017
city: Ivano-Frankivs'k
country: Ukraine
facility: Investigator Site 68-009
city: Ivano-Frankivs'k
country: Ukraine
facility: Investigator Site 68-005
city: Kharkiv
country: Ukraine
facility: Investigator Site 68-001
city: Kharkiv
country: Ukraine
facility: Investigator Site 68-011
city: Kharkiv
country: Ukraine
facility: Investigator Site 68-010
city: Kharkiv
country: Ukraine
facility: Investigator Site 68-002
city: Kyiv
country: Ukraine
facility: Investigator Site 68-012
city: Kyiv
country: Ukraine
facility: Investigator Site 68-003
city: Kyiv
country: Ukraine
facility: Investigator Site 68-015
city: Kyiv
country: Ukraine
facility: Investigator Site 68-013
city: Kyiv
country: Ukraine
facility: Investigator Site 68-007
city: Lviv
country: Ukraine
facility: Investigator Site 68-006
city: Vinnytsia
country: Ukraine
facility: Investigator Site 68-014
city: Zaporizhzhya
country: Ukraine
facility: Investigator Site 68-016
city: Zhytomyr
country: Ukraine
facility: Investigator Site 68-004
city: Harlow
country: United Kingdom
facility: Investigator Site 39-012
state: Essex
city: Scunthorpe
country: United Kingdom
facility: Investigator Site 39-003
state: North Lincolshire
city: Dudley
country: United Kingdom
facility: Investigator Site 39-005
state: West Midlands
city: Barnsley
country: United Kingdom
facility: Investigator Site 39-009
city: High Wycombe
country: United Kingdom
facility: Investigator Site 39-016
city: Inverness
country: United Kingdom
facility: Investigator Site 39-008
city: Leicester
country: United Kingdom
facility: Investigator Site 39-011
city: Liverpool
country: United Kingdom
facility: Investigator Site 39-013
city: London
country: United Kingdom
facility: Investigator Site 39-015
city: North Shields
country: United Kingdom
facility: Investigator Site 39-010
city: Swansea
country: United Kingdom
facility: Investigator Site 39-007
city: York
country: United Kingdom
facility: Investigator Site 39-004
Study officials:
affiliation: Vifor Pharma
name: Peter Szecsödy, MD
role: STUDY_DIRECTOR
References:
citation: Butler J, Anker SD, Lund LH, Coats AJS, Filippatos G, Siddiqi TJ, Friede T, Fabien V, Kosiborod M, Metra M, Pina IL, Pinto F, Rossignol P, van der Meer P, Bahit C, Belohlavek J, Bohm M, Brugts JJ, Cleland JGF, Ezekowitz J, Bayes-Genis A, Gotsman I, Goudev A, Khintibidze I, Lindenfeld J, Mentz RJ, Merkely B, Montes EC, Mullens W, Nicolau JC, Parkhomenko A, Ponikowski P, Seferovic PM, Senni M, Shlyakhto E, Cohen-Solal A, Szecsody P, Jensen K, Dorigotti F, Weir MR, Pitt B. Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial. Eur Heart J. 2022 Nov 1;43(41):4362-4373. doi: 10.1093/eurheartj/ehac401.
citation: Bolanos JA, Seliger SL. Recurrent Hyperkalemia in Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Treatment: Stuck between a Rock and a Hard Place. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):345-347. doi: 10.2215/CJN.00950121. Epub 2021 Feb 19. No abstract available.