The Efficacy and Mechanism of Trientine in Patients With Hypertrophic Cardiomyopathy

NCT04706429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2025-09-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Trientine

Trientine dihydrochloride is a white to pale yellow crystalline hygroscopic powder.

DRUG

Placebo

Placebo capsule, manufactured with the exact components of the trientine capsules, without the active ingredient / investigational medicinal product.

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV
  • University of Manchester

    collaborator OTHER
  • University of Liverpool

    collaborator OTHER
  • Univar BV

    collaborator INDUSTRY
  • University of Oxford

    collaborator OTHER
  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Chris Miller · Manchester University NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2024-04-30
Completion
2024-07-30

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04706429 on ClinicalTrials.gov