Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients

NCT ID: NCT02064868

Last Updated: 2019-03-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2666 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-04-25

Brief Summary

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This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).

Detailed Description

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This study was aimed at generating clinical evidence, especially on the short term period (in-hospital and at 30 days) to complement existing and future serelaxin data sets in Acute Heart Failure (AHF).

Conditions

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Acute Heart Failure (AHF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Serelaxin

Intervention Type DRUG

30 µg/kg/day IV infusion

Standard of Care

Intervention Type DRUG

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.

Group Type OTHER

Standard of Care

Intervention Type DRUG

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

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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RLX030

Eligibility Criteria

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Inclusion Criteria

* Systolic blood pressure ≥ 125 mmHg
* 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

* Dyspnea (non-cardiac causes)
* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

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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Vienna, , Austria

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Aalst, , Belgium

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Bruges, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Hasselt, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Lodelinsart, , Belgium

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Mol, , Belgium

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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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Sliven, , 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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Zagreb, , Croatia

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Brno, Czech Republic, Czechia

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Decin II, Czech Republic, Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Tallinn, , Estonia

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Tartu, , Estonia

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Turku, , Finland

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Marseille, Bouches Du Rhone, France

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Nancy, Cedex, France

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El Palmar, Murcia, Spain

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Oviedo, Principality of Asturias, Spain

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San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

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Alicante, Valencia, Spain

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Alicante, Valencia, Spain

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Alzira, Valencia, Spain

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Manises, Valencia, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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León, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Murcia, , Spain

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Zaragoza, , Spain

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Basel, , Switzerland

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Geneva, , Switzerland

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Liestal, , Switzerland

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Lugano, , Switzerland

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Durham, County Durham, United Kingdom

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Dorchester, Dorset, United Kingdom

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Peterborough, GBR, United Kingdom

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Gateshead, Tyne and Wear, United Kingdom

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Barnet, , United Kingdom

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Cardiff, , United Kingdom

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Dundee, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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Swindon, , United Kingdom

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Countries

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Austria Belgium Bulgaria Croatia Czechia Estonia Finland France Germany Greece Hungary Iceland Italy Latvia Lithuania Poland Portugal Romania Russia Serbia Slovakia Slovenia Spain Switzerland United Kingdom

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.

Reference Type DERIVED
PMID: 35184572 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34514815 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

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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