Heart failure & cardiomyopathies
Rationale and Design of ENDEAVOR: A Sequential Phase 2b–3 Randomized Clinical Trial to Evaluate the Effect of Myeloperoxidase Inhibition on Symptoms and Exercise Capacity in Heart Failure with Preserved or Mildly Reduced Ejection Fraction
Study context
- Population
- Patients with HF and EF >40% (HFpEF/HFmrEF), baseline 6MWD 30–400 m and Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS) ≤90 pointsphase 2b, planned
- Participants
- 660 patients
- Planned comparison
- Mitiperstat vs placebo
- Primary endpoint
- Dual: change from baseline in 6MWD and KCCQ-TSS
- Follow-up
- Week 16
Methodological detailsrationale and design, seamless phase 2b–3, placebo-controlled, Phase 2b: randomised 1:1:1 for 48 weeks, Safety monitored with a focus on maculopapular rash, 85% power to detect placebo-adjusted improvements of 21 m in 6MWD and 6.0 points in KCCQ-TSS at overall two-sided alpha of 0.05, Phase 3: ≈820 patients to be randomised 1:1 to mitiperstat or placebo
- Rationale and design
- Seamless phase 2b–3
- Placebo-controlled
- Phase 2b: randomised 1:1:1 for 48 weeks
- Safety monitored with a focus on maculopapular rash
- 85% power to detect placebo-adjusted improvements of 21 m in 6MWD and 6.0 points in KCCQ-TSS at overall two-sided alpha of 0.05
- Phase 3: ≈820 patients to be randomised 1:1 to mitiperstat or placebo
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Rationale and Design of ENDEAVOR: A Sequential Phase 2b–3 Randomized Clinical Trial to Evaluate the Effect of Myeloperoxidase Inhibition on Symptoms and Exercise Capacity in Heart Failure with Preserved or Mildly Reduced Ejection Fraction. Eur J Heart Fail. Published 22 August 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →