Heart failure & cardiomyopathies
Randomized Investigation of the MitraClip Device in Heart Failure: Design and Rationale of the RESHAPE-HF2 Trial Design
Study context
- Population
- Symptomatic chronic heart failure (HF) (NYHA II–IV despite optimal therapy) with moderate-to-severe or severe functional mitral regurgitation, EF ≥20% and ≤50%, HF hospitalisation or elevated natriuretic peptides in the last 90 days, isolated mitral valve surgery not recommendedrandomized
- Participants
- 506 participants
- Planned comparison
- Device vs Control
- Primary endpoint
- Three primary endpoints: (i) total (first and recurrent) HF hospitalisations and CV death; (ii) total HF hospitalisations; (iii) change in Kansas City Cardiomyopathy Questionnaire overall score (Hochberg procedure for familywise type I error)
- Follow-up
- 24 months (i, ii); 12 months (iii)
Methodological detailsinvestigator-initiated, prospective, parallel-controlled, multicentre
- Investigator-initiated
- Prospective
- Parallel-controlled
- Multicentre
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Randomized Investigation of the MitraClip Device in Heart Failure: Design and Rationale of the RESHAPE-HF2 Trial Design. Eur J Heart Fail. Published 23 April 2024. doi:10.
Summarised from the published abstract; every number is checked against it