TEMPEST
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, phase 2 evaluation of the efficacy and mechanism of trientine in patients with hypertrophic cardiomyopathy.
IRAS ID
283265
Contact name
Christopher Miller
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Eudract number
2020-002242-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Hypertrophic cardiomyopathy (HCM) is the most common inherited heart condition. It leads to abnormal thickening and scarring of the walls of the heart. As a result, the heart can have trouble pumping blood as well as it should. This causes patients to develop breathing difficulties, chest pain and fainting, which often get worse with exercise, and therefore can limit physical activity. Current treatments only aim to relieve the symptoms. There are no treatments that correct the underlying damage to the heart. Patients, caregivers and researchers have identified a “critical need” for trials of medicines that target the HCM disease process.
Several studies in other diseases have shown that copper imbalance is associated with heart thickening similar to HCM, and that treatment with trientine, an oral medicine that increases copper removal in urine, can reverse this thickening.
This study will investigate whether trientine reduces heart muscle thickening, improves exercise capacity, improves heart function and reduces abnormal heart rhythms in patients with HCM. The study will also assess how trientine works in HCM.
This research study aims to recruit 172 patients with HCM aged 18-70 years in the UK. Participants in the study will be prescribed either trientine or placebo for 1 year to compare the difference.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
20/NW/0275
Date of REC Opinion
21 Jul 2020
REC opinion
Further Information Favourable Opinion