Trimetazidine Therapy in Hypertrophic Cardiomyopathy
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Purpose
Hypertrophic cardiomyopathy (HCM) is a common inherited heart condition that causes breathlessness, chest pain and fatigue. There are few treatments available. The investigators have recently shown that a drug called perhexiline reduced symptoms and improved exercise capacity in patients with HCM. This change appears to be driven by alterations in myocardial energy metabolism. The aim of this trial is to test a similar drug, trimetazidine, in a group of symptomatic patients with non-obstructive HCM.
HYPOTHESIS: trimetazidine will improve symptoms, peak oxygen consumption, cardiac function and arrhythmia burden in medically refractory symptomatic patients with non-obstructive HCM.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertrophic Cardiomyopathy |
Drug: Trimetazidine Other: Placebo capsule |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2b Randomised, Double Blind, Placebo-controlled Trial of Trimetazidine Therapy in Patients With Non-obstructive Hypertrophic Cardiomyopathy |
- Peak oxygen consumption [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Left ventricular function [ Time Frame: 3 months ] [ Designated as safety issue: No ]TDI and 2D strain
- Symptom status [ Time Frame: 3 months ] [ Designated as safety issue: No ]questionnaire
- Arrhythmia [ Time Frame: 3 months ] [ Designated as safety issue: No ]24 Hour Holter
- Cardiac biomarkers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Exercise capacity [ Time Frame: 3 months ] [ Designated as safety issue: No ]6 minute walk test
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Trimetazidine |
Drug: Trimetazidine
Trimetazidine 20mg three times per day for 3 months
|
| Placebo Comparator: Placebo capsule |
Other: Placebo capsule
one capsule three times per day for 3 months
|
Detailed Description:
BACKGROUND:
Hypertrophic cardiomyopathy (HCM) is a common inherited disorder of heart muscle affecting 1 in 500 individuals worldwide. It is associated with arrhythmias, heart failure and sudden death in young people. In the majority of patients, HCM is caused by mutations in genes encoding cardiac contractile proteins. It has been hypothesised that excessive sarcomeric energy consumption is an important and early factor in the pathophysiology of HCM. Therefore modulation of myocardial metabolism presents a novel target for improving myocardial performance and symptoms in patients with HCM. Trimetazidine is an anti-anginal agent which like perhexiline reduces fatty acid oxidation and increases glucose oxidation, thus increasing the efficiency of energy production. Trimetazidine has been shown to significantly improve exercise performance in patients with stable angina, ischaemic and non ischaemic cardiomyopathy, either as monotherapy or in combination with beta-blockers or calcium channel blockers,
DESIGN: A single centre prospective randomised, double blind, placebo-controlled, trial of trimetazidine therapy.
DOSING: 20 mg Trimetazidine or Placebo three times daily for three months
METHODS: The following assessments will be made at baseline and after 3 months treatment: history and physical examination, Minnesota heart failure questionnaire, fasting blood tests, electrocardiogram, echocardiogram, cardiopulmonary exercise test, six minute walk test, 24 hour ECG Holter monitor.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Non-obstructive hypertrophic cardiomyopathy (gradient <30 mmHg at rest)
- NYHA (New York Heart Association) Class ≥ 2
- Peak VO2 (maximal oxygen consumption) ≤80% predicted for age and gender
- Heart rate < 90/minute at rest
Exclusion Criteria:
- Diabetes Mellitus
- Abnormal renal function (GFR<60ml/min) or hepatic impairment
- Female who is pregnant, lactating or planning pregnancy during the course of the study
Contacts and Locations| Contact: Perry M Elliott, MBBS MD | 020 3456 7898 | p.elliott@ucl.ac.uk |
| Contact: Caroline J Coats, MBBS | 020 3456 7898 | c.coats@ucl.ac.uk |
| United Kingdom | |
| The Heart Hospital, UCLH | Recruiting |
| London, United Kingdom, W1G 8PH | |
| Principal Investigator: | Perry M Elliott, MBBS MD | University College, London |
More Information
No publications provided
| Responsible Party: | University College, London |
| ClinicalTrials.gov Identifier: | NCT01696370 History of Changes |
| Other Study ID Numbers: | 10/0216 |
| Study First Received: | September 27, 2012 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University College, London:
|
Trimetazidine |
Additional relevant MeSH terms:
|
Cardiomyopathy, Hypertrophic Hypertrophy Cardiomyopathies Heart Diseases Cardiovascular Diseases Aortic Stenosis, Subvalvular Aortic Valve Stenosis |
Heart Valve Diseases Pathological Conditions, Anatomical Trimetazidine Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013