Heart failure & cardiomyopathiesRandomised controlled trial
Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity
- Randomised controlled trial
- international
- double-blind
- placebo-controlled
Authors' conclusion
Treatment with tirzepatide led to a lower risk of a composite of death from cardiovascular causes or worsening heart failure than placebo and improved health status in patients with heart failure with preserved ejection fraction and obesity.
Study context
- Population
- Patients with HF, EF ≥50% and BMI ≥30 (HFpEF and obesity)
- Participants
- 731 patients
- Comparison
- Tirzepatide vs placebo
- Tirzepatiden = 364
- Placebon = 367reference
- Primary endpoint
- Two primary end points: composite of adjudicated CV death or worsening HF event (time-to-first-event); change in Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS) (0–100, higher = better)
- Follow-up
- KCCQ-CSS: baseline to 52 weeks; median 104 weeks
Primary result
As reported in the abstract
Tirzepatide vs PlaceboHazard ratio (95% CI)P value
CV death or worsening HF event
0.62(0.41–0.95)
P = 0.026Tirzepatide vs PlaceboBetween-group difference (95% CI)P value
KCCQ-CSS change at 52 weeks
6.9(3.3–10.6)
P < 0.001Further findings
| Outcome | Tirzepatide | Placebo | HR (95% CI) | |
|---|---|---|---|---|
| Worsening HF events | 8.0% | 14.2% | 0.54 (0.34–0.85) | |
| Adjudicated CV death | 2.2% | 1.4% | 1.58 (0.52–4.83) | |
| 0.20.5125Hazard ratio (log scale) |
Safety
Adverse events (mainly gastrointestinal) leading to discontinuation of trial drug
Original publication
Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity. N Engl J Med. Published 16 November 2024. doi:10.1056/nejmoa2410027
Summarised from the published abstract; every number is checked against it