Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
NCT ID: NCT02064868
Last Updated: 2019-03-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
2666 participants
INTERVENTIONAL
2014-01-31
2017-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Serelaxin + Standard of Care
Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
Serelaxin
30 µg/kg/day IV infusion
Standard of Care
This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Standard of Care (SOC)
All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Standard of Care
This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Interventions
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Serelaxin
30 µg/kg/day IV infusion
Standard of Care
This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admitted for Acute Heart Failure (AHF)
* Received intravenous furosemide (or equivalent) at any time between presentation and the start of screening
* eGFR on admission: ≥ 25 and ≤75 mL/min/1.73 m\^2
Exclusion Criteria
* T \> 38.5°C
* Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
* Significant left ventricular outflow obstruction, uncorrected, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area \<1.0 cm\^2 or mean gradient \>50 mmHg on prior or current echocardiogram), severe aortic regurgitation and severe mitral stenosis.
* AHF due to significant arrhythmias
* Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Feldkirch, , Austria
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Graz, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Salzburg, , Austria
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Sankt Pölten, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Mons, , Belgium
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Roeselare, , Belgium
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Ronse, , Belgium
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Turnhout, , Belgium
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Gabrovo, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Varaždin, HRV, Croatia
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Countries
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References
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Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.
Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-002513-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRLX030A3301
Identifier Type: -
Identifier Source: org_study_id
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