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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 )

Tracking Information
First Submitted Date  ICMJE February 14, 2014
First Posted Date  ICMJE February 17, 2014
Results First Submitted Date  ICMJE April 24, 2018
Results First Posted Date  ICMJE March 22, 2019
Last Update Posted Date March 22, 2019
Actual Study Start Date  ICMJE January 31, 2014
Actual Primary Completion Date March 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
Change from baseline in worsening HF (WHF) requiring rescue therapy or all cause death, through Day 5 [ Time Frame: Baseline, Day 5 ]
Change History Complete list of historical versions of study NCT02064868 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 ]
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
  • Change from baseline in worsening HF (WHF) requiring rescue therapy or all cause death or readmission for heart failure and or renal failure through day 14 [ Time Frame: Baseline, Day 14 ]
  • Change from baseline in the number of patients with persistent symptoms or signs of Heart Failure (HF) or not showing improvement (persisting need of Intravenous therapy for HF) [ Time Frame: Baseline, Day 5 ]
  • Change from baseline in the rate of renal deterioration at day 5 [ Time Frame: Baseline, Day 5 ]
    Renal deterioration is defined as > or = 0.3 mg/dL increase in serum creatinine.
  • Length of hospital stay [ Time Frame: Up to Day 30 ]
    Length of stay (in hours) will be defined as the index discharge date and time minus the index hospitalization start date and time.
  • Number of patients reported with adverse events as assessment of safety and tolerability of Serelaxin in AHF patients [ Time Frame: Up to Day 30 ]
  • Change from baseline in Health-related quality of life, assessed by EuroQoL EQ-5D questionnaire [ Time Frame: Baseline, Day 5, Day 14 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
Official Title  ICMJE A Multicenter, Prospective, Randomized, Open-label Study to Assess the Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Heart Failure (AHF)
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Serelaxin + Standard of Care
    Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
    Interventions:
    • Drug: Serelaxin
    • Drug: Standard of Care
  • 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.
    Intervention: Drug: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 18, 2018)
2666
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2014)
2685
Actual Study Completion Date  ICMJE April 25, 2017
Actual Primary Completion Date March 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Bulgaria,   Croatia,   Czechia,   Estonia,   Finland,   France,   Germany,   Greece,   Hungary,   Iceland,   Italy,   Latvia,   Lithuania,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   Spain,   Switzerland,   United Kingdom
Removed Location Countries Czech Republic,   Denmark,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT02064868
Other Study ID Numbers  ICMJE CRLX030A3301
2013-002513-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP