drugset / Trial / NCT03547583
Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF
Phase 2
Completed
789 enrolled
Bayer
Canadian VIGOUR Centre · collabDuke Clinical Research Institute · collabMerck Sharp & Dohme LLC · collab
RandomizedParallel-groupQuadruple-blindTreatment
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
Outcome
Missed primary endpoint
paper 24-week treatment with vericiguat at either 15-mg/d or 10-mg/d dosages compared with placebo did not improve the physical limitation score of the KCCQ. PMID 33079152 ↗
registry analysis (other test); Vericiguat up to 10 mg vs Placebo; p = 0.8008; Difference of LS-means -0.52 (97.5% CI -5.17 to 4.13); Mixed model repeated-measures NCT03547583 ↗
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vericiguat | Other / unclassified | 10 mg | Oral |
| Subject | Vericiguat | Other / unclassified | 15 mg | Oral |