drugset / Trial / NCT04252287
A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine the superiority of the effectiveness of canagliflozin 100 milligram (mg) daily versus placebo in participants with symptomatic heart failure (HF) in improving the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS).
Timeline
- Start
- 2020-03-10
- Primary completion
- 2021-11-09
- Completion
- 2021-11-09
Outcome
Met primary endpoint
paper The 12-week change in KCCQ TSS was 4.3 points (95% confidence interval, 0.8-7.8; P = 0.016) higher with canagliflozin than with placebo, meeting the primary endpoint. PMID 35228753 ↗
registry analysis (superiority test); Placebo vs Canagliflozin 100 mg; p = 0.016; LS mean difference 4.3 (95% CI 0.8 to 7.8); ANCOVA NCT04252287 ↗
Publications
- Mohebi R, Jones PG, Spertus JA, Lingvay I, Lanfear DE, Gosch KL, Birmingham M, Kosiborod MN, Butler J, Januzzi JL Jr. Early Longitudinal Change in Heart Failure Health Status Following Initiation of Canagliflozin. JACC Heart Fail. 2024 Apr;12(4):711-718. doi: 10.1016/j.jchf.2024.01.005. Epub 2024 Feb 21.
- Golbus JR, Gosch K, Birmingham MC, Butler J, Lingvay I, Lanfear DE, Abbate A, Kosiborod ML, Damaraju CV, Januzzi JL Jr, Spertus J, Nallamothu BK. Association Between Wearable Device Measured Activity and Patient-Reported Outcomes for Heart Failure. JACC Heart Fail. 2023 Nov;11(11):1521-1530. doi: 10.1016/j.jchf.2023.05.033. Epub 2023 Jul 26.
- Nassif M, Birmingham MC, Lanfear DE, Golbus JR, Gupta B, Fawcett C, Harrison MC, Spertus JA. Recruitment Strategies of a Decentralized Randomized Placebo Controlled Clinical Trial: The Canagliflozin Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) Trial. J Card Fail. 2023 Jun;29(6):863-869. doi: 10.1016/j.cardfail.2023.04.001. Epub 2023 Apr 10.
- Spertus JA, Birmingham MC, Nassif M, Damaraju CV, Abbate A, Butler J, Lanfear DE, Lingvay I, Kosiborod MN, Januzzi JL. The SGLT2 inhibitor canagliflozin in heart failure: the CHIEF-HF remote, patient-centered randomized trial. Nat Med. 2022 Apr;28(4):809-813. doi: 10.1038/s41591-022-01703-8. Epub 2022 Feb 28.
- Spertus JA, Birmingham MC, Butler J, Lingvay I, Lanfear DE, Abbate A, Kosiborod ML, Fawcett C, Burton P, Damaraju CV, Januzzi JL, Whang J. Novel Trial Design: CHIEF-HF. Circ Heart Fail. 2021 Mar;14(3):e007767. doi: 10.1161/CIRCHEARTFAILURE.120.007767. Epub 2021 Mar 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CANAGLIFLOZIN ANHYDROUS | Small molecule | 100 mg | Oral |