Heart failure & cardiomyopathies
Endovascular Ablation of the Greater Splanchnic Nerve in Heart Failure With Preserved Ejection Fraction: The REBALANCE-HF Randomized Clinical Trial
Primary result · PCWP (legs-up and exercise)Result — go to the resultMean between-group difference −0.03 mm Hg 95% CI −2.5 to 2.5Authors' conclusion
Results show that SAVM was safe and technically feasible, but it did not reduce exercise PCWP at 1 month or improve clinical outcomes at 12 months in a broad population of patients with HFpEF.
Study context
- Population
- Patients with heart failure and preserved ejection fraction (HFpEF), LVEF ≥40% and invasively measured peak exercise pulmonary capillary wedge pressure (PCWP) ≥25 mm Hg
- Participants
- 90 patients
- Comparison
- SAVM vs Sham
- SAVMn = 44
- Shamn = 46reference
- Primary endpoint
- Reduction in legs-up and exercise PCWP
- Follow-up
- 1 month
Methodological detailsphase 2, double-blind, 1:1, sham-controlled, multicentre, 15 centres (14 US, 1 Republic of Georgia)
- Phase 2
- Double-blind
- 1:1
- Sham-controlled
- Multicentre
- 15 centres (14 US, 1 Republic of Georgia)
Primary result
PCWP (legs-up and exercise)
Mean between-group difference
−0.03 mm Hg
95% CI −2.5 to 2.5
P = 0.95
SAVM vs Sham
mean between-group difference −0.03 mm Hg (95% CI −2.5 to 2.5); P = 0.95
As reported in the abstract
Secondary outcomes
Secondary efficacy end points (HF hospitalisations, exercise function, health status through 12 months; 1-month change in resting, legs-up and 20-W exercise PCWP)
- No differences in the secondary efficacy end points
Safety
| Outcome | SAVM | Sham | Difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Serious device- or procedure-related adverse events (primary safety end point) · 1 month | 6.8% | 2.2% | 4.6% (−6.1% to 15.4%) | P = 0.36 | |
| Orthostatic hypotension | 11.4% | 6.5% | 4.9% (−9.2% to 18.8%) | P = 0.48 | |
| −1001020Difference (linear scale) |
Adverse events
- No differences in adverse events between groups
Original publication
Endovascular Ablation of the Greater Splanchnic Nerve in Heart Failure With Preserved Ejection Fraction: The REBALANCE-HF Randomized Clinical Trial. JAMA Cardiol. Published 1 December 2024. doi:10.
Summarised from the published abstract; every number is checked against it