Heart failure & cardiomyopathies

Design and Baseline Characteristics of STEP-HFpEF Program Evaluating Semaglutide in Patients With Obesity Heart Failure with Preserved Ejection Fraction (HFpEF) Phenotype

JACC Heart FailPublished Design and baseline characteristics report of two randomised controlled trials

Authors' conclusion

In total, STEP-HFpEF program randomized 1,146 participants with the obesity phenotype of HFpEF

Study context

Population
Adults with HFpEF (left ventricular ejection fraction (LVEF) ≥45%, NYHA II–IV, KCCQ-CSS <90) and BMI ≥30 kg/m², with or without T2DM529 STEP-HFpEF
Participants
1,146 adults
Comparison
Semaglutide 2.4 mg once weekly vs placebo
Primary endpoint
Dual: change in KCCQ-CSS and body weight
Follow-up
52 weeks
Methodological detailsinternational, multicentre, double-blind, placebo-controlled
  • International
  • Multicentre
  • Double-blind
  • Placebo-controlled

Primary result

As reported in the abstract

Baseline characteristics
Women
nearly half
Median BMI
37 kg/m²
Median LVEF
57%
SGLT2 inhibitor use in STEP-HFpEF DM
32%
SGLT2 inhibitor use in STEP-HFpEF
rare
MRA use
approximately one-third
KCCQ-CSS
∼59 points
6-minute walking distance
∼300 m

Original publication

Design and Baseline Characteristics of STEP-HFpEF Program Evaluating Semaglutide in Patients With Obesity HFpEF Phenotype. JACC Heart Fail. Published 21 May 2023. doi:10.1016/j.jchf.2023.05.010

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