Heart failure & cardiomyopathies
Macitentan for Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Pulmonary Vascular Disease: Results of the SERENADE Randomized Clinical Trial and Open-Label Extension Study
Primary result · Change in NT-proBNPResult — go to the resultGeometric mean ratio 1.02 90% CI 0.88–1.19Authors' conclusion
Despite a novel enrichment trial design to target pulmonary vascular disease and exclude treatment-related fluid retention in patients with HF and preserved/mildly reduced left ventricular ejection fraction, macitentan neither lowered NT-proBNP nor improved HF outcomes.
Study context
- Population
- Patients with heart failure (HF), left ventricular ejection fraction ≥40%, and pulmonary vascular disease who did not exhibit fluid retention during run-inrandomized, 230 enrolled, 28 excluded during placebo run-in, 60 excluded during macitentan run-in
- Participants
- 142 patients
- Comparison
- Macitentan or placebo
- Primary endpoint
- Change in NT-proBNP
- Follow-up
- Baseline to 24 weeks
Methodological details4-week placebo run-in, 5-week single-blind macitentan run-in, enrichment trial design
- 4-week placebo run-in
- 5-week single-blind macitentan run-in
- Enrichment trial design
Primary result
As reported in the abstract
Geometric mean ratio
1.02
90% CI 0.88–1.19
P = 0.79
Macitentanvs placebo
geometric mean ratio 1.02 (90% CI 0.88–1.19); P = 0.79
Secondary outcomes
| Outcome | Placebo-corrected change (90% CI) | P value | |
|---|---|---|---|
| Change in KCCQ clinical summary score (secondary) · baseline to 24 weeks | −3.5 (−8.2 to +1.2) | P = 0.22 | |
| −10−505Difference (linear scale) |
| Outcome | Macitentan | Placebo | Hazard ratio (90% CI) | P value | |
|---|---|---|---|---|---|
| Worsening HF (secondary) · by 52 weeks | 28% | 18% | 1.48 (0.83–2.67) | P = 0.24 | |
| 0.20.5125Hazard ratio (log scale) |
Safety
Fluid retention
Cardiac adverse events
Original publication
Macitentan for Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Pulmonary Vascular Disease: Results of the SERENADE Randomized Clinical Trial and Open-Label Extension Study. Circ Heart Fail. Published 11 March 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →