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).
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,666
30 µg/kg/day IV infusion
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.
Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5
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.
Time frame: 5 days
Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14
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.
Time frame: 14 days
Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5
Persistent or non-improvement in any signs or symptoms of HF at any post baseline visit up to Day 5.
Time frame: 5 days
Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14
Renal deterioration is defined as \> or = 0.3 mg/dL increase from screening in serum creatinine.
Time frame: 14 days
Length of Index Hospital Stay
Length of stay (in hours) is defined as the index hospitalization discharge date and time minus the index hospitalization start date and time.
Time frame: 30 Days
Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients
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Novartis Investigative Site
Feldkirch, Austria
Novartis Investigative Site
Graz, Austria
Novartis Investigative Site
Linz, Austria
Novartis Investigative Site
Salzburg, Austria
Novartis Investigative Site
Salzburg, Austria
Novartis Investigative Site
Sankt Pölten, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Aalst, Belgium
...and 347 more locations
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.
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).
Time frame: Baseline, Day 5, Day 14