Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF

Summary

The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.

Timeline

Start

2018-06-15

Primary completion

2019-10-15

Completion

2019-11-04

Publications

• Background Butler J, Lam CSP, Anstrom KJ, Ezekowitz J, Hernandez AF, O'Connor CM, Pieske B, Ponikowski P, Shah SJ, Solomon SD, Voors AA, Wu Y, Carvalho F, Bamber L, Blaustein RO, Roessig L, Armstrong PW. Rationale and Design of the VITALITY-HFpEF Trial. Circ Heart Fail. 2019 May;12(5):e005998. doi: 10.1161/CIRCHEARTFAILURE.119.005998.
• deFilippi CR, Shah P, Shah SJ, Alemayehu W, Lam CSP, Butler J, Roessig L, O'Connor CM, Westerhout CM, Armstrong PW; VITALITY-HFpEF Study Group. Proteomics Identify Clinical Phenotypes and Predict Functional Outcomes in Heart Failure With Preserved Ejection Fraction: Insights From VITALITY-HFpEF. Circ Heart Fail. 2024 Sep;17(9):e011792. doi: 10.1161/CIRCHEARTFAILURE.124.011792. Epub 2024 Aug 29.
• Kaul P, Rathwell S, Lam CSP, Westerhout CM, Spertus JA, Anstrom KJ, Blaustein RO, Ezekowitz JA, Pieske B, Roessig L, Butler J, Armstrong PW; VITALITY-HFpEF Study Group. Patient-Reported Frailty and Functional Status in Heart Failure With Preserved Ejection Fraction: Insights From VITALITY-HFpEF. JACC Heart Fail. 2023 Apr;11(4):392-403. doi: 10.1016/j.jchf.2022.11.015. Epub 2023 Feb 1.
• Armstrong PW, Lam CSP, Anstrom KJ, Ezekowitz J, Hernandez AF, O'Connor CM, Pieske B, Ponikowski P, Shah SJ, Solomon SD, Voors AA, She L, Vlajnic V, Carvalho F, Bamber L, Blaustein RO, Roessig L, Butler J; VITALITY-HFpEF Study Group. 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 Oct 20;324(15):1512-1521. doi: 10.1001/jama.2020.15922.

Drugs

Indications