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

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ClinicalTrials.gov Identifier: NCT02064868
Recruitment Status : Terminated (Study was terminated based on results from pivotal adult AHF study CRLX030A2301)
First Posted : February 17, 2014
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Acute Heart Failure (AHF) Drug: Serelaxin Drug: Standard of Care Phase 3

Detailed Description:
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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2666 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized, Open-label Study to Assess the Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
Actual Study Start Date : January 31, 2014
Actual Primary Completion Date : March 26, 2017
Actual Study Completion Date : April 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Serelaxin + Standard of Care
Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
 Drug: Serelaxin
30 µg/kg/day IV infusion
Other Name: RLX030

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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5 [ Time Frame: 5 days ]
    In-hospital WHF through Day 5 post-randomization included worsening signs and/or symptoms of heart failure that required an intensification of intravenous therapy for heart failure or mechanical ventilation, renal or circulatory support. A central event adjudication committee was appointed to oversee the WHF primary endpoint adjudication.


Secondary Outcome Measures :
  1. Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14 [ Time Frame: 14 days ]
    WHF/death/readmission for heart failure through Day 14. WHF/deaths through Day 5 were adjudicated and confirmed by the Clinical Endpoint Committee, WHF/deaths after Day 5 through Day 14 and readmission through Day 14 were as reported by the investigators.

  2. Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5 [ Time Frame: 5 days ]
    Persistent or non-improvement in any signs or symptoms of HF at any post baseline visit up to Day 5.

  3. Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14 [ Time Frame: 14 days ]
    Renal deterioration is defined as > or = 0.3 mg/dL increase from screening in serum creatinine.

  4. Length of Index Hospital Stay [ Time Frame: 30 Days ]
    Length of stay (in hours) is defined as the index hospitalization discharge date and time minus the index hospitalization start date and time.

  5. Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients [ Time Frame: Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days ]
  6. Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire. [ Time Frame: Baseline, Day 5, Day 14 ]
    EQ-5D-5L is a questionnaire designed to assess health status in adults consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The results were converted into a single index value using UK as the reference country for all countries. Range -0.3 (worst possible state) to 1 (best possible state).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064868


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] October 19, 2016
Statistical Analysis Plan  [PDF] February 27, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02064868    
Other Study ID Numbers: CRLX030A3301
2013-002513-35 ( EudraCT Number )
First Posted: February 17, 2014    Key Record Dates
Results First Posted: March 22, 2019
Last Update Posted: March 22, 2019
Last Verified: December 2018
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
AHF,
RLX030,
SOC,
 WHF,
RELAX-AHF-EU
Renal Impairment
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases