Heart failure & cardiomyopathiesRandomised controlled trial
Effects of volenrelaxin in worsening heart failure with preserved ejection fraction: a phase 2 randomized trial
- Randomised controlled trial
- phase 2
- double-blind
- international
- multicentre
- placebo-controlled
Authors' conclusion
In conclusion, despite some evidence for improvement in LA function at a low dose, treatment with this long-acting form of human relaxin was associated with worsening congestion in patients with recently decompensated HFpEF.
Study context
- Population
- New York Heart Association (NYHA) class II–IV heart failure and preserved ejection fraction (HFpEF) with recent heart failure (HF) decompensationenrolled before early stop
- Participants
- 332 participants
- Comparison
- Volenrelaxin vs placebo
- Primary endpoint
- Change in left atrial (LA) reservoir strain
- Follow-up
- 26 weeks
Primary result
As reported in the abstract
- 25-mg volenrelaxin
- difference +3.9 % (95% CI 1.1–6.6); P = 0.006
- 50-mg volenrelaxin
- difference +1.3 % (95% CI −1.3 to 3.9); P = 0.332
- 100-mg volenrelaxin
- difference +0.9 % (95% CI −1.8 to 3.6); P = 0.521
Secondary outcomes
| Outcome | Estimate |
|---|---|
| Change in NT-proBNP (all doses pooled) · 26 weeks · pooling all dosages; increased | change +24.5 % (95% CI 2.0–51.8) |
| Change in eGFR (all doses pooled) · 26 weeks · pooling all dosages; no significant effect | change +2.2 ml min-1 1.73 m-2 (95% CI −1.8 to 6.3) |
Safety
| Outcome | Estimate | P value | |
|---|---|---|---|
| HF hospitalization · non-significant increase | HR 2.64 (95% CI 0.93–7.56) | P = 0.070 | |
| CV and renal serious adverse events | OR 2.52 (95% CI 0.95–6.68) | P = 0.056 | |
| 0.10.31310Ratio (log scale) |
Original publication
Effects of volenrelaxin in worsening heart failure with preserved ejection fraction: a phase 2 randomized trial. Nat Med. Published 31 August 2025. doi:10.1038/s41591-025-03939-6
Summarised from the published abstract; every number is checked against it