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Could a Copper-Binding drug shrink thickened heart muscle?

NCT ID NCT04706429

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether the drug trientine can reduce heart muscle thickening and improve exercise ability in people with hypertrophic cardiomyopathy (HCM), a condition where the heart muscle becomes abnormally thick. 154 adults with HCM took either trientine or a placebo for 12 months. The main goal was to see if the drug could shrink the heart muscle and improve heart function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

154 people

The number who actually took part.

Started

Dec 2020

Finished

Jul 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Written informed consent. 2. Age 18-75 inclusive. 3. Hypertrophic cardiomyopathy (HCM), as defined by the European Society of Cardiology HCM guidelines as: "a wall thickness ≥15 mm in one or more LV myocardial segments that is not explained solely by loading conditions". The same definition is applied to first-degree relatives of patients with HCM i.e. all participants are required to have a LV wall thickness ≥15 mm. Wall thickness is as measured on the most recent cardiovascular magnetic resonance (CMR) scan performed prior to the baseline visit. If CMR has not been performed previously, wall thickness measurement should be taken from the most recent echocardiogram performed prior to the baseline visit. (It is recognised that in the European Society of Cardiology guidelines a clinical diagnosis of HCM in first-degree relatives requires a wall thickness that is less than this value, however ≥15 mm is applied here in order to ensure that all participants have an unequivocal phenotype). 4. New York Heart Association class I, II or III at the most recent clinical assessment performed prior to the baseline visit. Exclusion Criteria: 1. Previous or planned septal reduction therapy. 2. Previously documented myocardial infarction or severe coronary artery disease. 3. Uncontrolled hypertension, defined as a systolic blood pressure of \>180mmHg or a diastolic blood pressure of \> 100mmHg at Visit 1. 4. Known LV EF \< 50%, as measured on the most recent CMR scan performed prior to the baseline visit. If CMR has not been performed previously, the most recent echocardiogram performed prior to the baseline visit should be used. 5. Previously documented persistent atrial fibrillation. 6. Anaemia, defined as haemoglobin being below the local site normal reference range, at Visit 1. 7. Iron deficiency, defined as serum iron being below the local site normal reference range, at Visit 1. 8. Copper deficiency, defined as serum copper being below the normal reference range, at Visit 1. 9. Pacemaker or implantable cardioverter defibrillator. 10. Known severe valvular heart disease, as demonstrated on the most recent heart imaging performed prior to the baseline visit. 11. Previously documented other cardiomyopathic cause of myocardial hypertrophy (e.g. amyloidosis, Fabry disease, mitochondrial disease). 12. History of hypersensitivity to any of the components of the investigational medicinal product (IMP). 13. Known contraindication to MRI scanning. 14. Pregnancy, lactation or planning pregnancy. Women of childbearing capacity are required to have a negative serum pregnancy test before treatment, must agree to pregnancy tests at study visits as defined in the Section 8 and must agree to maintain highly effective contraception as defined in Section 8 during the study. 15. Any medical condition, which in the opinion of the Investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Liverpool Heart and Chester Hospital NHS Foundation Trust

    Liverpool, L14 3PE, United Kingdom

  • Manchester University NHS Foundation Trust

    Manchester, M23 9LT, United Kingdom

  • NHS Grampian

    Aberdeen, AB25 2ZN, United Kingdom

  • Northumbria Healthcare NHS Foundation Trust

    North Shields, NE29 8NH, United Kingdom

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU, United Kingdom

  • Royal Brompton and Harefield NHS Foundation Trust

    London, SW3 6NP, United Kingdom

  • University Hospitals of Leicester NHS Foundation Trust

    Leicester, LE3 9QP, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.