Clinical trial NCT04864795: Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia
Official title: Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia (CARE-HK in HF Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Hyperkalemia
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
First posted: 2021-04-29
Enrollment: 2636
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To the extent possible, representative sites (e.g., cardiologists and nephrologists) reflective of the treatment patterns within each country will be recruited. All patients treated for chronic HF during the enrolment period will be assessed for eligibility, and all eligible patients will be consecutively proposed to enrol in the study as they present for a routine clinical visit (in-person or virtual visits) in order to avoid potential selection bias.

Brief summary: The CARE-HK in HF is a registry study based on the hypothesis that adherence to guidelines is associated with improved real-world outcomes for heart failure (HF) patients. For the purpose of this study, adherence to guidelines is defined as adherence to RAASi treatment recommendations, according to the AHA/ACC and ESC guidelines. Objectives relating to patiromer effectiveness will only be evaluated if a sufficient number of patients are available.

The study aims to evaluate in patients at high risk of hyperkalaemia; patients treated with ACEi/ARB/ARNi, and either treated with or candidates for treatment with MRA.

Detailed description: The study will have an enrolment period of approximately 24 months, and each patient will be followed prospectively for at least 6 months. Each patient is expected to contribute to the study data collection until study end or until premature discontinuation, whichever occurs first (i.e., due to death, withdrawal of consent, or lost to follow-up).

At enrolment (informed consent signed by patient), relevant patient data will be retrospectively extracted from medical records for the 24 months prior to enrolment or since the time of HF diagnosis.

There are no visits or procedures associated with the study, patients will follow routine clinical care, which may include in-person and/or virtual visits. The study protocol does not recommend the use of any specific treatments and no study medication is provided as part of participation. The nature and heterogeneity of HF means patients will be treated with different treatments over the course of the study, and at the discretion of their treating physician.

Patient data will be collected from patient records and/or during a routine clinical visit and will be entered into the electronic Case Report Form (eCRF) via an electronic data capture (EDC) system. This will include treatments prescribed, routine assessments and measurements (e.g., laboratory parameters) collected at routine clinical visits, as well as hospitalisations and other relevant patient data. Protocol version 3.0, 19-Jul-2023

Eligibility criteria: Inclusion Criteria:

1. Adult aged ≥18 years at enrolment.
2. Patient diagnosed with chronic HF ≥3 months prior to signature of informed consent.
3. Patient has at least 1 record of LVEF documented in patient medical record in the 24 months prior to signature of informed consent. NOTE: If the proportion of patients with HFpEF exceeds 20% of the target sample size, enrolment of patients with an LVEF ≥50% may be capped.
4. Patient treated with ACEi/ARB/ARNi at enrolment.
5. Patient treated with or a candidate for treatment with MRA per a relevant treatment guideline (e.g., HF, CKD, resistant hypertension) at enrolment.
6. Patient at increased risk of hyperkalaemia due to one or more of the following:

   1. Current hyperkalaemia (sK+ \>5.0 mEq/l) at enrolment
   2. Record of documented hyperkalaemia (sK+ \>5.0 mEq/l) in the 24 months prior to signature of informed consent
   3. eGFR \<45 ml/min/1.73 m2, or CKD Stage ≥3b.
7. Patient judged by the Investigator to have sufficient cognitive ability to participate.
8. Signed informed consent provided

Exclusion Criteria:

1. Patient on renal replacement therapy or mechanical circulatory support.
2. Disease other than HF with expected survival \<1 year.
3. Patient is participating in, or being screened for, an interventional trial, with the exception of interventional trials relating to SARS-CoV-2.
4. Patient already found to be intolerant to MRA for reasons other than hyperkalaemia or renal impairment.

Primary outcomes:
measure: Percentage of patients by RAASi optimisation
timeFrame: at 6-months intervals
measure: Percentage of patients by RAASi dose modification following hyperkalaemic episodes
timeFrame: at 6-month intervals after a hyperkalaemic episode
measure: Comparison of percentage of patients with RAASi treatment optimisation between patiromer treated and untreated patients following hyperkalaemic
timeFrame: at 6-months following enrolment
Secondary outcomes:
measure: Occurrence and incidence of hyperkalaemia events by RAASi treatment optimisation
timeFrame: at 6-months following enrolment
measure: Description of physician provided reasons for treatment decisions at initiation or modification/discontinuation of RAASi treatment
timeFrame: up to 6 months following enrolment
measure: Description and change of disease status measured by patient reported outcome (PRO) by RAASi treatment optimisation
timeFrame: at enrolment and at approximately 6-months intervals
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: La Jolla
country: United States
facility: UC San Diego Sulpizio Cardiovascular Center
state: California
city: Northridge
country: United States
facility: Amicis Research Center
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Boynton Beach
country: United States
facility: Bethesda Hospital East
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Hialeah
country: United States
facility: Inpatient Research Clinic, LLC
state: Florida
city: Largo
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Miami
country: United States
facility: D&H National Research Centers
state: Florida
city: Naples
country: United States
facility: Southwest Florida Research, LLC
state: Florida
city: Port Charlotte
country: United States
facility: Peace River Cardiovascular Center
state: Florida
city: Safety Harbor
country: United States
facility: Clearwater Cardiovascular and Interventional Consultants
state: Florida
city: Winter Park
country: United States
facility: Florida Cardiology P.A
state: Florida
city: Columbus
country: United States
facility: IACT Health
state: Georgia
city: Eatonton
country: United States
facility: Cardiology Care Clinics
state: Georgia
city: Johns Creek
country: United States
facility: NSC Research
state: Georgia
city: Hazel Crest
country: United States
facility: Chicago Medical Research, LLC
state: Illinois
city: Springfield
country: United States
facility: Prairie Cardiovascular Consultants, Ltd.
state: Illinois
city: Davenport
country: United States
facility: Cardiovascular Medicine, P.C.
state: Iowa
city: Elizabethtown
country: United States
facility: Central Cardiology Associates
state: Kentucky
city: Biddeford
country: United States
facility: Maine Health
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Salisbury
country: United States
facility: TidalHealth Peninsula Regional Inc.
state: Maryland
city: Saginaw
country: United States
facility: Ascension St. Mary's Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Bridgeton
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Kalispell
country: United States
facility: Logan Health Research
state: Montana
city: Marlton
country: United States
facility: Virtua Medical Group PA
state: New Jersey
city: Matawan
country: United States
facility: Raritan Bay Primary and Cardiology Associates
state: New Jersey
city: Sewell
country: United States
facility: The Heart House
state: New Jersey
city: Albany
country: United States
facility: Albany Stratton VA Medical Center
state: New York
city: Albany
country: United States
facility: Capital Cardiology Associates
state: New York
city: Bay Shore
country: United States
facility: South Shore University Hospital
state: New York
city: Charlotte
country: United States
facility: Focus Clinical Research Solutions
state: North Carolina
city: Cincinnati
country: United States
facility: Nephrology Associates of Greater Cincinnati
state: Ohio
city: Marion
country: United States
facility: Rama Research LLC
state: Ohio
city: Durant
country: United States
facility: The Heart and Medical Center
state: Oklahoma
city: Camp Hill
country: United States
facility: Capital Area Research, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: East Texas Cardiology PA
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Kingwood
country: United States
facility: Texas Cardiology Associates of Houston
state: Texas
city: McKinney
country: United States
facility: Complete Heart Care
state: Texas
city: Round Rock
country: United States
facility: Baylor Scott & White Round Rock
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Health - Temple
state: Texas
city: Victoria
country: United States
facility: Victoria Heart & Vascular Center
state: Texas
city: Mechanicsville
country: United States
facility: Richmond Cardiology Associates
state: Virginia
city: Madison
country: United States
facility: William S. Middleton Memorial VA Hospital
state: Wisconsin
city: Braunau Am Inn
country: Austria
facility: KH St. Josef Braunau
city: Graz
country: Austria
facility: LKH Universitatklinikum Graz
city: Linz
country: Austria
facility: Ordensklinkum Linz Elisabethinen
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien
city: Wien
country: Austria
facility: Imed-19 privat
city: Wien
country: Austria
facility: Klinik Floridsdorf
city: Brussels
country: Belgium
facility: Cliniques Universitaires de Bruxelles Hopital Erasme
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Liège
country: Belgium
facility: CHU de Liège
city: Ronse
country: Belgium
facility: AZ Glorieux
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
city: Ferrara
country: Italy
facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
city: Monza
country: Italy
facility: Centro Cardiologico Monzino-IRCCS
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria "Federico II"
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
city: Roma
country: Italy
facility: IRCCS San Raffaele Pisana
city: San Martino
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Triest
country: Italy
facility: Azienda Servizi Sanitari 1 Triestina
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Huelva
country: Spain
facility: Juan Ramon Jimenez Hospital
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaen
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrin
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Málaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Puerto Real
country: Spain
facility: Hospital Universitario Puerto Real
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Tarragona
country: Spain
facility: Hosp. Universitari Sant Joan de Reus
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau AG
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève - HUG
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Amersham
country: United Kingdom
facility: Buckinghamshire Healthcare NHS Trust
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: William Harvey Clinical Research Centre
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Rainhill
country: United Kingdom
facility: Whiston Hospital
Study officials:
affiliation: Vifor International
name: Sandra Wächter
role: STUDY_CHAIR
References: