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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00475852




Registration number
NCT00475852
Ethics application status
Date submitted
18/05/2007
Date registered
21/05/2007
Date last updated
8/03/2013

Titles & IDs
Public title
A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure
Scientific title
Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF)
Secondary ID [1] 0 0
ASCEND-HF
Secondary ID [2] 0 0
CR013954
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Decompensation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nesiritide
Treatment: Drugs - Placebo

Experimental: 001 - Nesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs)

Placebo comparator: 002 - Placebo matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs


Treatment: Drugs: Nesiritide
0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Treatment: Drugs: Placebo
matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality
Timepoint [1] 0 0
Randomization to Day 30
Primary outcome [2] 0 0
Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug
Timepoint [2] 0 0
6 hours after initiation of study drug
Primary outcome [3] 0 0
Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug
Timepoint [3] 0 0
24 hours after study drug initiation
Secondary outcome [1] 0 0
Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug
Timepoint [1] 0 0
6 hours after study drug initiation
Secondary outcome [2] 0 0
Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug
Timepoint [2] 0 0
24 hours after study drug initiation
Secondary outcome [3] 0 0
Composite of Persistent or Worsening Heart Failure and All-Cause Mortality
Timepoint [3] 0 0
Randomization to hospital discharge (up to Day 30)
Secondary outcome [4] 0 0
Number of Days Alive and Outside the Hospital
Timepoint [4] 0 0
Randomization to Day 30
Secondary outcome [5] 0 0
Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality
Timepoint [5] 0 0
Randomization to Day 30

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
7141
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bedford
Recruitment hospital [2] 0 0
- Camperdown N/A
Recruitment hospital [3] 0 0
- Concord
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- Darlinghurst
Recruitment hospital [5] 0 0
- Elizabeth Vale
Recruitment hospital [6] 0 0
- Fitzroy
Recruitment hospital [7] 0 0
- Hobart
Recruitment hospital [8] 0 0
- Kogarah
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- Launceston
Recruitment hospital [10] 0 0
- Melbourne
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- Randwick
Recruitment postcode(s) [1] 0 0
- Bedford
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- Camperdown N/A
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- Concord
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- Darlinghurst
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- Elizabeth Vale
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- Fitzroy
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- Hobart
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- Kogarah
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- Launceston
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- Melbourne
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- Randwick
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Hastings
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Nelson
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Bydgoszcz
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Gdynia
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Poland
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Krakow
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Poland
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Ostrowiec Swietokrzyski
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Poland
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Skierniewice
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Tomsk
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Russian Federation
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Tumen
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Singapore
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Singapore
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Sweden
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Falun
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Sweden
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Uppsala
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Kaohsiung
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Taipei
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Tao-Yuan
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Thailand
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Bangkok
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Khon Kaen
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Ukraine
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Dnepropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Kharkov
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Ukraine
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Lviv
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Ukraine
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Nikolaev
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Ukraine
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Vinnitsa
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Ukraine
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Zaporozhye

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Scios, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00475852
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Toma M, Ezekowitz JA, Bakal JA, O'Connor CM, Hernandez AF, Sardar MR, Zolty R, Massie BM, Swedberg K, Armstrong PW, Starling RC. The relationship between left ventricular ejection fraction and mortality in patients with acute heart failure: insights from the ASCEND-HF Trial. Eur J Heart Fail. 2014 Mar;16(3):334-41. doi: 10.1002/ejhf.19. Epub 2013 Dec 14.
Reed SD, Kaul P, Li Y, Eapen ZJ, Davidson-Ray L, Schulman KA, Massie BM, Armstrong PW, Starling RC, O'Connor CM, Hernandez AF, Califf RM. Medical resource use, costs, and quality of life in patients with acute decompensated heart failure: findings from ASCEND-HF. J Card Fail. 2013 Sep;19(9):611-20. doi: 10.1016/j.cardfail.2013.07.003.
Howlett JG, Ezekowitz JA, Podder M, Hernandez AF, Diaz R, Dickstein K, Dunlap ME, Corbalan R, Armstrong PW, Starling RC, O'Connor CM, Califf RM, Fonarow GC; ASCEND-HF Investigators. Global variation in quality of care among patients hospitalized with acute heart failure in an international trial: findings from the acute study clinical effectiveness of nesiritide in decompensated heart failure trial (ASCEND-HF). Circ Cardiovasc Qual Outcomes. 2013 Sep 1;6(5):534-42. doi: 10.1161/CIRCOUTCOMES.113.000119. Epub 2013 Jul 30.
Eapen ZJ, Reed SD, Li Y, Kociol RD, Armstrong PW, Starling RC, McMurray JJ, Massie BM, Swedberg K, Ezekowitz JA, Fonarow GC, Teerlink JR, Metra M, Whellan DJ, O'Connor CM, Califf RM, Hernandez AF. Do countries or hospitals with longer hospital stays for acute heart failure have lower readmission rates?: Findings from ASCEND-HF. Circ Heart Fail. 2013 Jul;6(4):727-32. doi: 10.1161/CIRCHEARTFAILURE.112.000265. Epub 2013 Jun 14.
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O'Connor CM, Starling RC, Hernandez AF, Armstrong PW, Dickstein K, Hasselblad V, Heizer GM, Komajda M, Massie BM, McMurray JJ, Nieminen MS, Reist CJ, Rouleau JL, Swedberg K, Adams KF Jr, Anker SD, Atar D, Battler A, Botero R, Bohidar NR, Butler J, Clausell N, Corbalan R, Costanzo MR, Dahlstrom U, Deckelbaum LI, Diaz R, Dunlap ME, Ezekowitz JA, Feldman D, Felker GM, Fonarow GC, Gennevois D, Gottlieb SS, Hill JA, Hollander JE, Howlett JG, Hudson MP, Kociol RD, Krum H, Laucevicius A, Levy WC, Mendez GF, Metra M, Mittal S, Oh BH, Pereira NL, Ponikowski P, Tang WH, Tanomsup S, Teerlink JR, Triposkiadis F, Troughton RW, Voors AA, Whellan DJ, Zannad F, Califf RM. Effect of nesiritide in patients with acute decompensated heart failure. N Engl J Med. 2011 Jul 7;365(1):32-43. doi: 10.1056/NEJMoa1100171. Erratum In: N Engl J Med. 2011 Aug 25;365(8):773. Wilson, W H [corrected to Tang, W H W].
Public notes

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Scios, Inc. Clinical Trial
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00475852