Heart failure & cardiomyopathies
Phenotype Characterization of Heart Failure with Preserved Ejection Fraction in Medical Device and Surgical Trials
Authors' conclusion
However, despite many trials of a medical device or surgical procedure showing proof of concept to treat HFpEF phenotypes, they do not provide sufficient evidence of long-term benefit.
Study context
- Population
- Heart failure with preserved ejection fraction (HFpEF) patients (left ventricular ejection fraction (LVEF) ≥50% and signs of diastolic dysfunction) in medical device or surgical intervention trials
- Participants
- 1,752 patients24 trials
- Comparison
- Interatrial shunt device vs Atrial flow regulator vs Vagal nerve stimulation vs Baroreflex activation therapy vs Cardiac contractility modulator vs CRT vs Functional electrical stimulation therapy vs Renal denervation vs Greater splanchnic nerve ablation vs Catheter ablation vs Pericardiotomy
- Interatrial shunt devicen = 1,069
- Atrial flow regulatorn = 41
- Vagal nerve stimulationn = 112
- Baroreflex activation therapyn = 21
- Cardiac contractility modulatorn = 47
- CRTn = 178
- Functional electrical stimulation therapyn = 89
- Renal denervationn = 25
- Greater splanchnic nerve ablationn = 111
- Catheter ablationn = 55
- Pericardiotomyn = 4
- Outcome
- Trials identified, by intervention type and phase
Methodological detailsPRISMA, descriptive analysis, methodology quality assessment
- PRISMA
- Descriptive analysis
- Methodology quality assessment
Pooled result
As reported in the abstract
- Novel trials identified
- 24
- Medical device trials
- 17
- Interatrial shunt device trials
- 3 (n = 1069)
- Atrial flow regulator trial
- 1 (n = 41)
- Vagal nerve stimulation trials
- 3 (n = 112)
- Baroreflex activation therapy trial
- 1 (n = 21)
- Cardiac contractility modulator trial
- 1 (n = 47)
- CRT trials
- 6 (n = 178)
- Functional electrical stimulation therapy trials
- 2 (n = 89)
- Surgical intervention trials
- 7
- Renal denervation trial
- 1 (n = 25)
- Greater splanchnic nerve ablation trials
- 3 (n = 111)
- Catheter ablation trials
- 2 (n = 55)
- Pericardiotomy procedure trial
- 1 (n = 4)
- Completed phase 3 trials
- 1
- Completed phase 1 trials with further trials
- 20
- Completed phase 1 trials without further trials
- 5
- Trials demonstrating at least safety and feasibility
- 16 out of 24
Original publication
Phenotype Characterization of Heart Failure with Preserved Ejection Fraction in Medical Device and Surgical Trials. ESC Heart Fail. Published 26 August 2025. doi:10.
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