Evaluate the Efficacy and Safety of the Oral sGC Stimulator Vericiguat to Improve Physical Functioning in Daily Living Activities of Patients With Heart Failure and Preserved Ejection Fraction - VITALITY-HFpEF

Nov 02, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Bayer and Merck
Date Published:
10/20/2020
Date Updated:
11/02/2020
Original Posted Date:
11/02/2020
References

Contribution To Literature:

The VITALITY-HFpEF trial failed to show that vericiguat improved a physical limitation score.

Description:

The goal of the trial was to evaluate the oral soluble guanylate cyclase stimulator vericiguat compared with placebo among patients with heart failure with preserved ejection fraction (HFpEF).

Study Design

  • Randomized
  • Parallel
  • Double-blind
  • Placebo

Patients with HFpEF were randomized to vericiguat 15 mg daily (n = 264) versus vericiguat 10 mg daily (n = 263) versus placebo (n = 262).

  • Total number of enrollees: 789
  • Duration of follow-up: 24 weeks
  • Mean patient age: 73 years
  • Percentage female: 49%

Inclusion criteria:

  • Chronic heart failure with left ventricular ejection fraction ≥45%
  • New York Heart Association class II-III symptoms
  • Decompensated heart failure within the last 6 months
  • Elevated natriuretic peptides

Principal Findings:

The primary outcome, Kansas City Cardiomyopathy Questionnaire (KCCQ) physical limitation score at baseline and 24 weeks, was 60.0 and 68.3 in the vericiguat 15 mg group, versus 57.3 and 69.0 in the vericiguat 10 mg group, versus 59.0 and 67.1 in the placebo group, respectively. The least-squares mean difference in scores was -1.5 between the 15 mg and placebo groups (p = 0.47) and -0.5 between the 10 mg and placebo groups (p = 0.80). 

Secondary outcomes:

  • Symptomatic hypotension: 6.4% in the vericiguat 15 mg group, 4.2% in the vericiguat 10 mg group, and 3.4% in the placebo group
  • Syncope: 1.5% in the vericiguat 15 mg group, 0.8% in the vericiguat 10 mg group, and 0.4% in the placebo group

Interpretation:

Among patients with HFpEF, vericiguat was not superior to placebo at improving physical limitation score of the KCCQ. Symptomatic hypotension and syncope were numerically increased in the vericiguat (15 mg) group.

References:

Armstrong PW, Lam CS, Anstrom KJ, et al. Effect of Vericiguat vs Placebo on Quality of Life in Patients With Heart Failure and Preserved Ejection Fraction: The VITALITY-HFpEF Randomized Clinical Trial. JAMA 2020;324:1512-21.

Editorial: Clark KA, Velazquez EJ. Heart Failure With Preserved Ejection Fraction: Time for a Reset. JAMA 2020;324:1506-8.

Clinical Topics: Cardiovascular Care Team, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Activities of Daily Living, Cardiomyopathies, Geriatrics, Heart Failure, Hypotension, Motor Activity, Natriuretic Peptides, Quality of Life, Stroke Volume, Syncope


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