Heart failure & cardiomyopathiesRandomised controlled trial
Percutaneous Repair of Moderate-to-Severe or Severe Functional Mitral Regurgitation in Patients with Symptomatic Heart Failure: Baseline Characteristics of Patients in the RESHAPE-HF2 Trial and Comparison to COAPT and MITRA-FR Trials
- Baseline characteristics report of the RESHAPE-HF2 randomised trial
- investigator-initiated
- prospective
- multicentre
- 1:1 randomisation
Authors' conclusion
Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials.
Study context
- Population
- Symptomatic heart failure (HF), left ventricular ejection fraction (LVEF) 20%–50%, moderate-to-severe or severe functional mitral regurgitation (FMR), isolated mitral valve surgery not recommendedrandomised
- Participants
- 506 participants
- Comparison
- MitraClip vs Withholding MitraClip
Primary result
As reported in the abstract
Baseline characteristics · baseline
- Age, mean ± SD (years)
- 70 ± 10
- Women
- 99 (20%)
- EuroSCORE II, median (IQR)
- 5.3 (2.8-9.0)
- NT-proBNP, median (IQR), pg/ml
- 2745 (1407-5385)
- Beta-blockers
- 96%
- Diuretics
- 96%
- ACEi/ARB/ARNI
- 82%
- MRA
- 82%
- SGLT2 inhibitors
- 7%
- Prior cardiac resynchronization therapy (CRT) device
- 29%
- LVEF, mean ± SD
- 31 ± 8%
- LV end-diastolic volume, mean ± SD
- 211 ± 76 ml
- Effective regurgitant orifice area (EROA), mean ± SD
- 0.25 ± 0.08 cm²
- MR grade 4+
- 44%
Further findings
Comparison with COAPT and MITRA-FR populations · baseline
- RESHAPE-HF2 less likely to have MR grade 4+, lower EROA and NT-proBNP, higher eGFR; similar age, comorbidities, CRT therapy and LVEF
Original publication
Percutaneous Repair of Moderate-to-Severe or Severe Functional Mitral Regurgitation in Patients with Symptomatic Heart Failure: Baseline Characteristics of Patients in the RESHAPE-HF2 Trial and Comparison to COAPT and MITRA-FR Trials. Eur J Heart Fail. Published 7 June 2024. doi:10.1002/ejhf.3286
Summarised from the published abstract; every number is checked against it