Status:
COMPLETED
The Efficacy and Mechanism of Trientine in Patients With Hypertrophic Cardiomyopathy
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
University of Manchester
Conditions:
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Detailed Description
HCM is the most common inherited cardiovascular disorder. It is characterised by left ventricular (LV) myocardial hypertrophy and fibrosis. Patients can experience symptoms of effort intolerance, prog...
Eligibility Criteria
Inclusion
- Written informed consent.
- Age 18-75 inclusive.
- 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).
- New York Heart Association class I, II or III at the most recent clinical assessment performed prior to the baseline visit.
Exclusion
- Previous or planned septal reduction therapy.
- Previously documented myocardial infarction or severe coronary artery disease.
- Uncontrolled hypertension, defined as a systolic blood pressure of \>180mmHg or a diastolic blood pressure of \> 100mmHg at Visit 1.
- 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.
- Previously documented persistent atrial fibrillation.
- Anaemia, defined as haemoglobin being below the local site normal reference range, at Visit 1.
- Iron deficiency, defined as serum iron being below the local site normal reference range, at Visit 1.
- Copper deficiency, defined as serum copper being below the normal reference range, at Visit 1.
- Pacemaker or implantable cardioverter defibrillator.
- Known severe valvular heart disease, as demonstrated on the most recent heart imaging performed prior to the baseline visit.
- Previously documented other cardiomyopathic cause of myocardial hypertrophy (e.g. amyloidosis, Fabry disease, mitochondrial disease).
- History of hypersensitivity to any of the components of the investigational medicinal product (IMP).
- Known contraindication to MRI scanning.
- 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.
- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2024
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT04706429
Start Date
December 1 2020
End Date
July 30 2024
Last Update
September 29 2025
Active Locations (7)
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1
NHS Grampian
Aberdeen, United Kingdom, AB25 2ZN
2
University Hospitals of Leicester NHS Foundation Trust
Leicester, United Kingdom, LE3 9QP
3
Liverpool Heart and Chester Hospital NHS Foundation Trust
Liverpool, United Kingdom, L14 3PE
4
Royal Brompton and Harefield NHS Foundation Trust
London, United Kingdom, SW3 6NP