The Efficacy and Mechanism of Trientine in Patients With Hypertrophic Cardiomyopathy

Sponsor
Manchester University NHS Foundation Trust
Study ID
NCT04706429
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Trientine — DRUG
    Trientine dihydrochloride is a white to pale yellow crystalline hygroscopic powder.
  • Placebo — DRUG
    Placebo capsule, manufactured with the exact components of the trientine capsules, without the active ingredient / investigational medicinal product.

Study Details

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.

Key Dates

First listed
Jan 12, 2021
Start date
Dec 1, 2020
Status verified
Sep 2025
Primary completion
Apr 30, 2024
Completion
Jul 30, 2024

Study Design

Enrollment
154 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Trientine
    Trientine dihydrochloride 1200 mg per day. This shall be taken orally as two Cufence 200mg hard capsules two times per day. The IMP will be dispensed to participants every 13 weeks for the duration of the study period (52 weeks).
  • Placebo Comparator: Placebo
    The placebo shall be taken orally as two capsules two times per day. This will be dispensed to participants every 13 weeks for the duration of the study period (52 weeks).

Primary Outcome Measure

Left ventricular mass indexed to body surface area (LVMi) [ Time Frame: 12 months ]

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