Heart failure & cardiomyopathiesRandomised controlled trial
Randomized Investigation of the MitraClip Device in Heart Failure: Design and Rationale of the RESHAPE-HF2 Trial Design
- Design and rationale of the RESHAPE-HF2 randomised trial
- investigator-initiated
- prospective
- parallel-controlled
- multicentre
Authors' conclusion
The RESHAPE-HF2 trial will provide sound evidence on the MitraClip device and its effects in HF patients with FMR.
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
- 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)
Primary result
As reported in the abstract
- design paper; no results reported
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:10.1002/ejhf.3247
Summarised from the published abstract; every number is checked against it