Clinical trial NCT00475852: A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure
Official title: Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Decompensation
Keywords: Heart Decompensation
Dyspnea
Heart failure
Nesiritide
Decompensated
ADHF
Lead sponsor: Scios, Inc.
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 7141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if nesiritide (a human B-type natriuretic peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart failure, helps to improve breathing difficulties, reduce heart failure readmissions to hospitals, and helps patients live longer.

Detailed description: Acute Decompensated Heart Failure (ADHF) is the inability of the heart to pump efficiently, which can result in symptoms like shortness of breath at rest or with minimal activity. ADHF is a condition in which the heart cannot perform the necessary circulation of blood through the body. This is a randomized (study medication is assigned by chance), double-blind (neither the patient or the doctor knows whether the patient is assigned to receive study drug or placebo \[does not contain study drug\]), placebo-controlled, parallel group, multicenter study of the effectiveness of nesiritide administered continuously through a vein for a minimum of 24 hours up to a maximum of 7 days. The study hypothesis is that nesiritide given in addition to standard care is superior to placebo given in addition to standard care as measured by relief of breathing difficulties (by patient evaluation utilizing a breathlessness scale) at 6 hours or 24 hours after nesiritide administration, and reduction in rehospitalization due to heart failure and death from study drug administration through Day 30. The study drug (nesiritide) or placebo dose being studied is 0.010 mcg/kg/min with or without a 2 mcg/kg initial bolus (one time injection) of nesiritide. Patient safety will be monitored throughout the study through physical exams, vital signs (heart rate, blood pressure, respiratory rate, and temperature), blood tests, and side effects. The patients assigned to the nesiritide group will receive a continuous intravenous (into a vein) infusion at 0.010 mcg/kg/min of nesiritide with or without a 2 mcg/kg bolus (one time injection). The patients assigned to the placebo group will receive matching placebo bolus and infusion. The bolus is given over one minute and the continuous infusion is given for at least 24 hours and up to 7 days.

Eligibility criteria: Inclusion Criteria:

Hospitalized for the management of acute decompensated heart failure (ADHF) or diagnosed with ADHF within 48 hours after being hospitalized for another reason; Diagnosis of ADHF is defined as dyspnea (difficulty breathing) at rest or dyspnea with minimal activity.

Exclusion Criteria:

At high risk for hypotension (low blood pressure); Acute coronary syndrome as primary diagnosis; History of cardiac valvular stenosis, restrictive cardiomyopathy, hypertrophic cardiomyopathy, or pericardial tamponade; Previous enrollment in a nesiritide study; Persistent, uncontrolled hypertension (SBP \[systolic blood pressure\] \>180 mmHg).

Primary outcomes:
measure: Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality
timeFrame: Randomization to Day 30
measure: Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug
timeFrame: 6 hours after initiation of study drug
measure: Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug
timeFrame: 24 hours after study drug initiation
Secondary outcomes:
measure: Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug
timeFrame: 6 hours after study drug initiation
measure: Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug
timeFrame: 24 hours after study drug initiation
measure: Composite of Persistent or Worsening Heart Failure and All-Cause Mortality
timeFrame: Randomization to hospital discharge (up to Day 30)
measure: Number of Days Alive and Outside the Hospital
timeFrame: Randomization to Day 30
measure: Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality
timeFrame: Randomization to Day 30
Other outcomes:
measure: All-Cause Mortality Through Day 30
timeFrame: Randomization to Day 30
measure: All-Cause Mortality Through Day 180
timeFrame: Randomization to Day 180
measure: Cardiovascular Mortality Through Day 30
timeFrame: Randomization to Day 30
measure: Number of Patients With Renal Impairment
timeFrame: Study drug initiation to Day 30
Locations:
city: Huntsville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Gilbert
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Fort Smith
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Berkeley
country: United States
state: California
city: Culver City
country: United States
state: California
city: Escondido
country: United States
state: California
city: Inglewood
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Ventura
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Fort Collins
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Newark
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state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Clearwater
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Inverness
country: United States
state: Florida
city: Lakeland
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Atlanta
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state: Georgia
city: Augusta
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state: Georgia
city: Gainesville
country: United States
state: Georgia
city: Macon
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state: Georgia
city: Aurora
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state: Illinois
city: Chicago
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state: Illinois
city: Downers Grove
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city: Elk Grove Village
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state: Illinois
city: Hinsdale
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state: Illinois
city: La Grange
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state: Illinois
city: Maywood
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state: Illinois
city: Mokena
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state: Illinois
city: Oakbrook Terrace
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city: Peoria
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state: Indiana
city: Indianapolis
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city: Munster
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city: South Bend
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state: Kentucky
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state: Kentucky
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state: Maryland
city: Randallstown
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state: Massachusetts
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state: Michigan
city: Detroit
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city: Flint
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city: Lansing
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city: Monroe
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city: Petoskey
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city: Pontiac
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city: Troy
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city: Minneapolis
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city: Brown Mills
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city: Paterson
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city: Ridgewood
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city: Toms River
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city: Turnersville
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city: Bronx
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city: Brooklyn
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state: New York
city: Elmhurst
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city: Johnson City
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city: New Hyde Parke
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state: New York
city: Poughkeepsie
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city: Rochester
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city: Roslyn
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city: Saratoga Springs
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state: North Carolina
city: Chapel Hill
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state: North Carolina
city: Charlotte
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state: North Carolina
city: Durham
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city: Cincinnati
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city: Columbus
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city: Dayton
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city: Garfield Heights
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city: Mansfield
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city: Natrona Heights
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city: Philadelphia
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city: York
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city: Anderson
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state: South Carolina
city: Charleston
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state: South Carolina
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state: Washington
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city: Cordoba
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city: La Plata
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city: Elizabeth Vale
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city: Launceston
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city: Melbourne
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city: Randwick
country: Australia
city: Belo Horizonte
country: Brazil
city: Campinas
country: Brazil
city: Curitiba
country: Brazil
city: Fortaleza
country: Brazil
city: Goiânia
country: Brazil
city: Porto Alegre
country: Brazil
city: Recife
country: Brazil
city: Rio De Janeiro-Rj
country: Brazil
city: Salvador
country: Brazil
city: Sao Jose Do Rio Preto
country: Brazil
city: Sao Paulo
country: Brazil
city: São José Do Rio Preto
country: Brazil
city: Pleven
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Red Deer
country: Canada
state: Alberta
city: Campbell River
country: Canada
state: British Columbia
city: Kelowna
country: Canada
state: British Columbia
city: Maple Ridge
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state: British Columbia
city: New Westminster
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state: British Columbia
city: Surrey
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
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state: British Columbia
city: Lakeland
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state: Manitoba
city: Winnipeg
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state: Manitoba
city: Halifax
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state: Nova Scotia
city: Ajax
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state: Ontario
city: Brampton
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state: Ontario
city: Cornwall
country: Canada
state: Ontario
city: Hamilton
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state: Ontario
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city: Ottawa
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state: Ontario
city: Scarborough
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city: Toronto
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state: Ontario
city: Granby
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state: Quebec
city: Laval
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Saint-Charles-Borromee
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Ste-Foy
country: Canada
state: Quebec
city: Terrebonne
country: Canada
state: Quebec
city: Santiago Rm
country: Chile
city: Santiago
country: Chile
city: Temuco
country: Chile
city: Beijing Prc
country: China
city: Beijing
country: China
city: Guangdong Province
country: China
city: Hangzhou
country: China
city: Jinan
country: China
city: Shanghai
country: China
city: Tianjin
country: China
city: Xian
country: China
city: Barranquilla
country: Colombia
city: Bogotá Dc
country: Colombia
city: Floridablanca
country: Colombia
city: Colmar
country: France
city: Paris
country: France
city: Poitiers
country: France
city: Pontoise
country: France
city: Thionville Cedex N/A
country: France
city: Toulouse
country: France
city: Valenciennes
country: France
city: Vandoeuvre Les Nancy Cedex
country: France
city: Bad Krozingen
country: Germany
city: Berlin
country: Germany
city: Brandenburg
country: Germany
city: Ludwigshafen
country: Germany
city: Lüdenscheid
country: Germany
city: Neuruppin
country: Germany
city: Athens
country: Greece
city: Larisa
country: Greece
city: Thessalonikis
country: Greece
city: Volos
country: Greece
city: Ahmedabad
country: India
city: Bangalore N/A
country: India
city: Coimbatore
country: India
city: Hyderabad
country: India
city: Nagpur
country: India
city: Pune
country: India
city: Vadodara
country: India
city: Hadera
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Petah Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Safed
country: Israel
city: Chungcheongbuk-Do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Kaunas
country: Lithuania
city: Vilnius Lt
country: Lithuania
city: Johor Bahru
country: Malaysia
city: Kuala Lumpur N/A
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Aguascalientes
country: Mexico
city: Guadalajara
country: Mexico
city: San Luis Potosi
country: Mexico
city: Sinaloa
country: Mexico
city: Zapopan
country: Mexico
city: Amersfoort
country: Netherlands
city: Delft
country: Netherlands
city: Gorinchem
country: Netherlands
city: Groningen
country: Netherlands
city: Leeuwarden
country: Netherlands
city: Sneek
country: Netherlands
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Hamilton
country: New Zealand
city: Hastings
country: New Zealand
city: Lower Hutt
country: New Zealand
city: Nelson
country: New Zealand
city: Stavanger
country: Norway
city: Trondheim
country: Norway
city: Tønsberg
country: Norway
city: Bydgoszcz
country: Poland
city: Gdynia
country: Poland
city: Krakow
country: Poland
city: Ostrowiec Swietokrzyski
country: Poland
city: Skierniewice
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Ekaterinburg
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Moscow
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Tumen
country: Russian Federation
city: Singapore
country: Singapore
city: Falun
country: Sweden
city: Uppsala
country: Sweden
city: Kaohsiung
country: Taiwan
city: Taipei
country: Taiwan
city: Tao-Yuan
country: Taiwan
city: Bangkok
country: Thailand
city: Khon Kaen
country: Thailand
city: Dnepropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkov
country: Ukraine
city: Lviv
country: Ukraine
city: Nikolaev
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Zaporozhye
country: Ukraine
Study officials:
affiliation: Scios, Inc.
name: Scios, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Cosiano MF, Vista A, Sun JL, Alhanti B, Harrington J, Butler J, Starling RC, Mentz RJ, Greene SJ. Comparing New York Heart Association Class and Patient-Reported Outcomes Among Patients Hospitalized for Heart Failure. Circ Heart Fail. 2023 Jan;16(1):e010107. doi: 10.1161/CIRCHEARTFAILURE.122.010107. Epub 2022 Oct 31.
citation: Blumer V, Mentz RJ, Sun JL, Butler J, Metra M, Voors AA, Hernandez AF, O'Connor CM, Greene SJ. Prognostic Role of Prior Heart Failure Hospitalization Among Patients Hospitalized for Worsening Chronic Heart Failure. Circ Heart Fail. 2021 Apr;14(4):e007871. doi: 10.1161/CIRCHEARTFAILURE.120.007871. Epub 2021 Mar 29.
citation: Greene SJ, DeVore AD, Sheng S, Fonarow GC, Butler J, Califf RM, Hernandez AF, Matsouaka RA, Samman Tahhan A, Thomas KL, Vaduganathan M, Yancy CW, Peterson ED, O'Connor CM, Mentz RJ. Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF. JACC Heart Fail. 2019 Nov;7(11):980-992. doi: 10.1016/j.jchf.2019.07.011. Epub 2019 Oct 9.
citation: Greene SJ, Hernandez AF, Sun JL, Butler J, Armstrong PW, Ezekowitz JA, Zannad F, Ferreira JP, Coles A, Metra M, Voors AA, Califf RM, O'Connor CM, Mentz RJ. Relationship Between Enrolling Country Income Level and Patient Profile, Protocol Completion, and Trial End Points. Circ Cardiovasc Qual Outcomes. 2018 Oct;11(10):e004783. doi: 10.1161/CIRCOUTCOMES.118.004783.
citation: Verma AK, Sun JL, Hernandez A, Teerlink JR, Schulte PJ, Ezekowitz J, Voors A, Starling R, Armstrong P, O'Conner CM, Mentz RJ. Rate pressure product and the components of heart rate and systolic blood pressure in hospitalized heart failure patients with preserved ejection fraction: Insights from ASCEND-HF. Clin Cardiol. 2018 Jul;41(7):945-952. doi: 10.1002/clc.22981. Epub 2018 Jul 17.
citation: Bhatt AS, Cooper LB, Ambrosy AP, Clare RM, Coles A, Joyce E, Krishnamoorthy A, Butler J, Felker GM, Ezekowitz JA, Armstrong PW, Hernandez AF, O'Connor CM, Mentz RJ. Interaction of Body Mass Index on the Association Between N-Terminal-Pro-b-Type Natriuretic Peptide and Morbidity and Mortality in Patients With Acute Heart Failure: Findings From ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure). J Am Heart Assoc. 2018 Feb 3;7(3):e006740. doi: 10.1161/JAHA.117.006740.
citation: Greene SJ, Hernandez AF, Dunning A, Ambrosy AP, Armstrong PW, Butler J, Cerbin LP, Coles A, Ezekowitz JA, Metra M, Starling RC, Teerlink JR, Voors AA, O'Connor CM, Mentz RJ. Hospitalization for Recently Diagnosed Versus Worsening Chronic Heart Failure: From the ASCEND-HF Trial. J Am Coll Cardiol. 2017 Jun 27;69(25):3029-3039. doi: 10.1016/j.jacc.2017.04.043.
citation: Greene SJ, Hernandez AF, Sun JL, Metra M, Butler J, Ambrosy AP, Ezekowitz JA, Starling RC, Teerlink JR, Schulte PJ, Voors AA, Armstrong PW, O'Connor CM, Mentz RJ. Influence of Clinical Trial Site Enrollment on Patient Characteristics, Protocol Completion, and End Points: Insights From the ASCEND-HF Trial (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure). Circ Heart Fail. 2016 Sep;9(9):e002986. doi: 10.1161/CIRCHEARTFAILURE.116.002986.
citation: Ezekowitz JA, Podder M, Hernandez AF, Armstrong PW, Starling RC, O'Connor CM, Califf RM. Arrival by ambulance in acute heart failure: insights into the mode of presentation from Acute Studies of Nesiritide in Decompensated Heart Failure (ASCEND-HF). BMJ Open. 2016 Mar 17;6(3):e010201. doi: 10.1136/bmjopen-2015-010201.
citation: Abualnaja S, Podder M, Hernandez AF, McMurray JJ, Starling RC, O'Connor CM, Califf RM, Armstrong PW, Ezekowitz JA. Acute Heart Failure and Atrial Fibrillation: Insights From the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF) Trial. J Am Heart Assoc. 2015 Aug 24;4(8):e002092. doi: 10.1161/JAHA.115.002092.
citation: Patel PA, Heizer G, O'Connor CM, Schulte PJ, Dickstein K, Ezekowitz JA, Armstrong PW, Hasselblad V, Mills RM, McMurray JJ, Starling RC, Tang WH, Califf RM, Hernandez AF. Hypotension during hospitalization for acute heart failure is independently associated with 30-day mortality: findings from ASCEND-HF. Circ Heart Fail. 2014 Nov;7(6):918-25. doi: 10.1161/CIRCHEARTFAILURE.113.000872. Epub 2014 Oct 3.
citation: van Deursen VM, Hernandez AF, Stebbins A, Hasselblad V, Ezekowitz JA, Califf RM, Gottlieb SS, O'Connor CM, Starling RC, Tang WH, McMurray JJ, Dickstein K, Voors AA. Nesiritide, renal function, and associated outcomes during hospitalization for acute decompensated heart failure: results from the Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure (ASCEND-HF). Circulation. 2014 Sep 16;130(12):958-65. doi: 10.1161/CIRCULATIONAHA.113.003046. Epub 2014 Jul 29.
citation: Kaul P, Reed SD, Hernandez AF, Howlett JG, Ezekowitz JA, Li Y, Zheng Y, Rouleau JL, Starling RC, O'Connor CM, Califf RM, Armstrong PW. Differences in treatment, outcomes, and quality of life among patients with heart failure in Canada and the United States. JACC Heart Fail. 2013 Dec;1(6):523-30. doi: 10.1016/j.jchf.2013.07.004. Epub 2013 Oct 23.
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