Randomised controlled trial
Ertugliflozin for Functional Mitral Regurgitation Associated With Heart Failure: EFFORT Trial
- Randomised controlled trial
- multicentre
- double-blind
Authors' conclusion
Among patients with functional MR associated with HF, ertugliflozin significantly improved LV global longitudinal strain and left atrial remodeling, and reduced functional MR.
Study context
- Population
- Patients with heart failure (HF) (NYHA II or III, 35%≤EF<50%) and chronic functional mitral regurgitation (MR) (effective regurgitant orifice area >0.1 cm² at baseline echocardiography)
- Participants
- 128 patients
- Comparison
- Ertugliflozin vs Placebo
- Primary endpoint
- Change in effective regurgitant orifice area of functional MR
- Follow-up
- baseline to 12-month follow-up
Primary result
As reported in the abstract
Change in effective regurgitant orifice area · 12 months
Ertugliflozin
−0.05
SD 0.06 · cm²
Placebo
0.03
SD 0.12 · cm²
P < 0.001
Secondary outcomes
| Outcome | Estimate | P value |
|---|---|---|
| Regurgitant volume | reduction 11.2 mL (95% CI −16.1 to −6.3) | P = 0.009 |
| Left atrial volume index | reduction 6.0 mL/m² (95% CI −12.16 to 0.15) | P = 0.005 |
| LV global longitudinal strain | reduction 1.44 % (95% CI −2.42% to −0.46%) | P = 0.004 |
Left ventricular (LV) volume indices, EF, NT-proBNP
- No significant between-group differences
Safety
Serious adverse events
P = 0.12
Original publication
Ertugliflozin for Functional Mitral Regurgitation Associated With Heart Failure: EFFORT Trial. Circulation. Published 1 May 2024. doi:10.1161/circulationaha.124.069144
Summarised from the published abstract; every number is checked against it