Heart failure & cardiomyopathies

Effects of Semaglutide on Symptoms, Function, and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction and Obesity: A Prespecified Analysis of the STEP-HFpEF Trial

CirculationPublished Secondary analysis of the STEP-HFpEF randomised trial

Authors' conclusion

In patients with HFpEF and obesity, semaglutide produced large improvements in HF-related symptoms, physical limitations, exercise function, inflammation, body weight, and N-terminal pro-brain natriuretic peptide, regardless of baseline health status. The benefits of semaglutide extended to all key KCCQ domains.

Study context

Population
Symptomatic heart failure (HF), EF ≥45% and BMI ≥30 kg/m², stratified by baseline KCCQ-CSS tertiles
Participants
529 participants
Comparison
Semaglutide 2.4 mg once weekly vs placebo
Primary endpoint
Dual primary end points: change in KCCQ-CSS and body weight, across baseline KCCQ-CSS tertiles
Follow-up
52 weeks
Methodological detailsprespecified analysis
  • Prespecified analysis

Primary result

As reported in the abstract

Change in KCCQ-CSS and body weight by baseline KCCQ-CSS tertile (baseline median 37, 59, 77 points)
Semaglutide vs PlaceboEstimated treatment difference, points (95% CI)
KCCQ-CSS, tertile 1
10.7(5.4–16.1)
KCCQ-CSS, tertile 2
8.1(2.7–13.4)
KCCQ-CSS, tertile 3
4.6(−0.6 to 9.9)
Semaglutide vs PlaceboEstimated treatment difference (95% CI)
Body weight, tertile 1
−11(−13.2 to −8.8)
Body weight, tertile 2
−9.4(−11.5 to −7.2)
Body weight, tertile 3
−11.8(−14.0 to −9.6)

Secondary outcomes

Confirmatory secondary and exploratory end points (6-minute walk distance, hierarchical composite, CRP, NT-proBNP) across tertiles

Consistent effects across KCCQ-CSS tertiles
P for interaction > 0.1 for all

All key Kansas City Cardiomyopathy Questionnaire (KCCQ) domains

Estimated treatment differences across domains
6.7-9.6 points; P≤0.001 for all

≥5-, 10-, 15- and 20-point improvement in all KCCQ domains

Greater proportion with semaglutide vs placebo; ORs across domains
1.6-2.9; P<0.05 for all

Original publication

Effects of Semaglutide on Symptoms, Function, and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction and Obesity: A Prespecified Analysis of the STEP-HFpEF Trial. Circulation. Published 12 November 2023. doi:10.1161/circulationaha.123.067505

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