Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure
Summary
The purpose of this study is to evaluate the effect of treatment with omecamtiv mecarbil compared with placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment with omecamtiv mecarbil or placebo
Timeline
- Start
- 2019-04-09
- Primary completion
- 2021-11-08
- Completion
- 2022-01-06
Outcome
Missed primary endpoint
registry analysis (superiority test); Omecamtiv Mecarbil vs Placebo; p = 0.13; Least squares mean difference -0.447 (95% CI -1.024 to 0.131); ANCOVA NCT03759392 ↗
paper Mean change in peak V̇o2 did not differ significantly between the omecamtiv mecarbil and placebo groups PMID 35852527 ↗
release “There was no effect on the primary endpoint, which was the change in peak oxygen uptake (pVO2) on CPET” cytokinetics.com ↗
release “METEORIC-HF: No Effect of Treatment with Omecamtiv Mecarbil on Exercise Capacity” cytokinetics.com ↗
Publications
- Lewis GD, Voors AA, Cohen-Solal A, Metra M, Whellan DJ, Ezekowitz JA, Bohm M, Teerlink JR, Docherty KF, Lopes RD, Divanji PH, Heitner SB, Kupfer S, Malik FI, Meng L, Wohltman A, Felker GM. Effect of Omecamtiv Mecarbil on Exercise Capacity in Chronic Heart Failure With Reduced Ejection Fraction: The METEORIC-HF Randomized Clinical Trial. JAMA. 2022 Jul 19;328(3):259-269. doi: 10.1001/jama.2022.11016.
- Lewis GD, Docherty KF, Voors AA, Cohen-Solal A, Metra M, Whellan DJ, Ezekowitz JA, Ponikowski P, Bohm M, Teerlink JR, Heitner SB, Kupfer S, Malik FI, Meng L, Felker GM. Developments in Exercise Capacity Assessment in Heart Failure Clinical Trials and the Rationale for the Design of METEORIC-HF. Circ Heart Fail. 2022 May;15(5):e008970. doi: 10.1161/CIRCHEARTFAILURE.121.008970. Epub 2022 Mar 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omecamtiv Mecarbil | Small molecule | 25 mg | Oral |
| Subject | Omecamtiv Mecarbil | Small molecule | 37.5 mg | Oral |
| Subject | Omecamtiv Mecarbil | Small molecule | 50 mg | Oral |