18 and older, any sex, with Acute Heart Failure (AHF). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5Primary· 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.
Group
Value
95% CI
Serelaxin + Standard of Care
4.95
Standard of Care (SOC)
6.94
Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14Secondary· 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.
Group
Value
95% CI
Serelaxin + Standard of Care
8.49
Standard of Care (SOC)
10.63
Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5Secondary· 5 days
Persistent or non-improvement in any signs or symptoms of HF at any post baseline visit up to Day 5.
Group
Value
95% CI
Serelaxin + Standard of Care
86
84 – 87
Standard of Care (SOC)
91
89 – 93
Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14Secondary· 14 days
Renal deterioration is defined as \> or = 0.3 mg/dL increase from screening in serum creatinine.
Group
Value
95% CI
Serelaxin + Standard of Care
36
34 – 38
Standard of Care (SOC)
44
40 – 47
Length of Index Hospital StaySecondary· 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.
Group
Value
95% CI
Serelaxin + Standard of Care
251.28
± 162.368
Standard of Care (SOC)
243.59
± 160.270
Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF PatientsSecondary· Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days
Patients with any AE through Day 5
Group
Value
95% CI
Serelaxin + Standard of Care
58.13
Standard of Care (SOC)
56.04
Patients with any SAE through Day 14
Group
Value
95% CI
Serelaxin + Standard of Care
12.38
Standard of Care (SOC)
11.97
All cause deaths through Day 5
Group
Value
95% CI
Serelaxin + Standard of Care
0.58
Standard of Care (SOC)
0.67
All cause deaths through Day 14
Group
Value
95% CI
Serelaxin + Standard of Care
1.91
Standard of Care (SOC)
2.01
All cause deaths through Day 30
Group
Value
95% CI
Serelaxin + Standard of Care
3.30
Standard of Care (SOC)
4.25
Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire.Secondary· 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).
Day 5
Group
Value
95% CI
Serelaxin + Standard of Care
0.28
± 0.298
Standard of Care (SOC)
0.27
± 0.292
Day 14
Group
Value
95% CI
Serelaxin + Standard of Care
0.32
± 0.328
Standard of Care (SOC)
0.31
± 0.317
Adverse events — posted to ClinicalTrials.gov
Time frame: All Cause Mortality: 30 days (additional deaths are included which occurred after the clinical trial reporting period of 30 days for up to 8 months post randomization); Serious Adverse Events: 14 days; Other non-serious Adverse Events (AEs): 5 days.
Reporting threshold: 1.5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02625922 — Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart
· Phase 2
· terminated
NCT02151383 — Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure
· Phase 2
· terminated
NCT02007720 — Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF
· Phase 3
· terminated
NCT01979614 — Study of the Vascular Effects of Serelaxin
· Phase 2
· completed
Other recruiting trials for Acute Heart Failure (AHF)
Currently open trials in the same condition.
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 22 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02064868.