drugset / Trial / NCT04706429
The Efficacy and Mechanism of Trientine in Patients With Hypertrophic Cardiomyopathy
Phase 2
Completed
154 enrolled
Manchester University NHS Foundation Trust
National Institute for Health Research, United Kingdom · collabUnivar BV · collabUniversity of Liverpool · collabUniversity of Manchester · collabUniversity of Oxford · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This research study has been designed to test whether a drug called trientine dihydrochloride (also called Cufence) reduces heart muscle thickening, improves exercise capacity, improves heart function and reduces abnormal heart rhythms in patients with hypertrophic cardiomyopathy (HCM). The study is also assessing how trientine works in HCM. Participants will be prescribed either trientine or placebo, for a period of 12 months.
Timeline
- Start
- 2020-12-01
- Primary completion
- 2024-04-30
- Completion
- 2024-07-30
Publications
- Farrant JP, Dodd S, Rosala-Hallas A, Vaughan C, Spowart C, Bedson E, Clayton D, Reid AB, Garratt CJ, Raman B, Mahmod M, Akhtar M, Valkovic L, Ashkir Z, Cooper R, Singh A, Prasad S, Green T, Dawson D, Moon JC, Baroja O, Duran B, Naish J, Harrington CF, Garg S, Graham C, Mohiddin S, Dweck MR, Greenlaw N, Plein S, Berry C, Schmitt M, Neubauer S, Miller CA. Trientine for hypertrophic cardiomyopathy: a phase 2 trial. Eur Heart J. 2026 Jul 15:ehag512. doi: 10.1093/eurheartj/ehag512. Online ahead of print.
- Farrant J, Dodd S, Vaughan C, Reid A, Schmitt M, Garratt C, Akhtar M, Mahmod M, Neubauer S, Cooper RM, Prasad SK, Singh A, Valkovic L, Raman B, Ashkir Z, Clayton D, Baroja O, Duran B, Spowart C, Bedson E, Naish JH, Harrington C, Miller CA; TEMPEST investigators. Rationale and design of a randomised trial of trientine in patients with hypertrophic cardiomyopathy. Heart. 2023 Jul 12;109(15):1175-1182. doi: 10.1136/heartjnl-2022-322271.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | trientine | Unknown | 1200 mg | Oral |