Heart failure & cardiomyopathiesRandomised controlled trial
Baroreflex Activation Therapy in Patients with Heart Failure and a Reduced Ejection Fraction: Long-Term Outcomes
- Randomised controlled trial
- prospective
- multicentre
- two-arm
- parallel-group
- open-label
- non-implanted control
Authors' conclusion
The BeAT-HF primary endpoint was neutral; however, BAT provided safe, effective, and sustainable improvements in HFrEF patient's functional status, 6MHWD and QOL.
Study context
- Population
- New York Heart Association (NYHA) class III heart failure with reduced ejection fraction (HFrEF) (EF ≤35%), prior HF hospitalization or NT-proBNP >400 pg/ml, NT-proBNP <1600 pg/ml, no class I CRT indication332 primary events
- Participants
- 323 participants
- Comparison
- Baroreflex activation therapy (BAT) plus optimal medical management vs optimal medical management alone
- Primary endpoint
- CV mortality and HF morbidity
- Follow-up
- Median 3.6 years/patient
Primary result
As reported in the abstract
Rate ratio
0.94
95% CI 0.57–1.57
P = 0.82
BAT vs Control
rate ratio 0.94 (95% CI 0.57–1.57); P = 0.82
Further findings
| Outcome | win ratio (95% CI) | |
|---|---|---|
| Hierarchical composite win ratio · did not reach statistical significance | 1.26 (1.02–1.58) | |
| 0.512Win ratio (log scale) |
| Outcome | HR (95% CI) | |
|---|---|---|
| Freedom from all-cause death, LVAD implantation, heart transplant · did not reach statistical significance | 0.66 (0.43–1.01) | |
| 0.512Hazard ratio (log scale) |
Symptoms (quality of life (QOL), 6MHWD, NYHA class)
- Durable, sustainable improvement with BAT
- all nominal p < 0.001
Safety
| Outcome | BAT | Control |
|---|---|---|
| System- and procedure-related major adverse neurological and CV event-free rate · throughout the trial | 97% | Not reported in the abstract |
Original publication
Baroreflex Activation Therapy in Patients with Heart Failure and a Reduced Ejection Fraction: Long-Term Outcomes. Eur J Heart Fail. Published 12 April 2024. doi:10.1002/ejhf.3232
Summarised from the published abstract; every number is checked against it