Rationale and Design of the VITALITY-HFpEF Trial

Javed Butler, Carolyn S.P. Lam, Kevin J. Anstrom, Justin Ezekowitz, Adrian F. Hernandez, Christopher M. O'Connor, Burkert Pieske, Piotr Ponikowski, Sanjiv J. Shah, Scott D. Solomon, Adriaan A. Voors, Yi Wu, Francine Carvalho, Luke Bamber, Robert O. Blaustein, Lothar Roessig, Paul W. Armstrong*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

Background The VITALITY-HFpEF trial (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) is designed to determine the efficacy and safety of a novel oral soluble guanylate cyclase stimulator, vericiguat, on quality of life and exercise tolerance in heart failure patients with preserved ejection fraction (HFpEF). Impaired physical functioning reduces the quality of life in patients with HFpEF. The primary goal of HF treatment along with improving survival is to improve function, reduce symptoms, and maximize quality of life. Abnormal cyclic guanosine monophosphate signaling may contribute to physical limitations in patients with HFpEF via central and peripheral mechanisms. Exploratory post hoc analyses from a prior trial showed that vericiguat can improve patient-relevant domains of the Kansas City Cardiomyopathy Questionnaire, especially the physical limitation score. Methods and Results VITALITY-HFpEF is a placebo-controlled, double-blind, multi-center, phase IIb trial of ≈735 patients, ≥45 years with HFpEF and ejection fraction ≥45% who will be randomized 1:1:1 to placebo, 10 mg, or 15 mg vericiguat. The primary end point is change in Kansas City Cardiomyopathy Questionnaire physical limitation score from baseline to week 24 and change in 6-minute walk test from baseline to week 24 is the secondary end point. Conclusions VITALITY-HFpEF is the first trial designed to assess the efficacy of vericiguat in patients with HFpEF using the Kansas City Cardiomyopathy Questionnaire physical limitation score as a novel primary end point. This study will also extend the prior dosing experience with vericiguat in HF by studying the safety and efficacy of a 15 mg dose. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT03547583.

Original languageEnglish (US)
Article numbere005998
JournalCirculation: Heart Failure
Volume12
Issue number5
DOIs
StatePublished - May 1 2019

Keywords

  • heart failure
  • quality of life
  • safety
  • soluble guanylate cyclase
  • survival

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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