Hypertrophic Cardiomyopathy Clinical Trial
— METAL-HCMOfficial title:
Metabolic Alteration With Perhexiline Therapy in Patients With Hypertrophic Cardiomyopathy (METAL-HCM Study)
Verified date | August 2010 |
Source | University Hospital Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
Hypertrophic Cardiomyopathy (HCM) is a relatively common inherited heart muscle disease.
Many patients experience symptoms of breathlessness, fatigue and chest pain. These symptoms
are not always controlled with current therapies.
Recently the investigators showed that a drug called Perhexiline markedly improved exercise
capacity and symptoms in patients with heart failure. In this proposal the investigators
wish to test whether Perhexiline improves exercise capacity and relieves symptoms in
patients with HCM
Status | Completed |
Enrollment | 44 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Symptomatic Hypertrophic Cardiomyopathy patients 2. Abnormal Peak VO2 3. No significant LVOT obstruction at rest (gradient < 30mmHg) 4. Sinus rhythm Exclusion Criteria: 1. Abnormal LFT. 2. Concomitant use of amiodarone 3. Pre-existing evidence of peripheral neuropathy. 4. Women of childbearing potential. 5. Patients with ICD's will be excluded from the MR part of the study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Birmingham | Birmingham | West Midlands |
United Kingdom | heart Hospital, University College of London NHS | London | |
United Kingdom | University of Oxford | Oxford |
Lead Sponsor | Collaborator |
---|---|
University Hospital Birmingham | British Heart Foundation, University College London Hospitals, University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak oxygen consumption (Vo2max) | 3-4 months | ||
Secondary | LV function (TDI and 2DS Echo) | 3-4 months | ||
Secondary | Symptomatic Status (questionnaire) | 3-4 months | ||
Secondary | Resting myocardial energetics (31P Cardiac MR Spectroscopy) | 3-4 months | ||
Secondary | Diastolic function at rest and during exercise (Nuclear studies) | 3-4 months |
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