Trimetazidine Therapy in Hypertrophic Cardiomyopathy
|ClinicalTrials.gov Identifier: NCT01696370|
Recruitment Status : Unknown
Verified August 2011 by University College, London.
Recruitment status was: Recruiting
First Posted : October 1, 2012
Last Update Posted : February 28, 2013
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 or disease||Intervention/treatment||Phase|
|Hypertrophic Cardiomyopathy||Drug: Trimetazidine Other: Placebo capsule||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2b Randomised, Double Blind, Placebo-controlled Trial of Trimetazidine Therapy in Patients With Non-obstructive Hypertrophic Cardiomyopathy|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||April 2014|
|Active Comparator: 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
- Peak oxygen consumption [ Time Frame: 3 months ]
- Left ventricular function [ Time Frame: 3 months ]TDI and 2D strain
- Symptom status [ Time Frame: 3 months ]questionnaire
- Arrhythmia [ Time Frame: 3 months ]24 Hour Holter
- Cardiac biomarkers [ Time Frame: 3 months ]
- Exercise capacity [ Time Frame: 3 months ]6 minute walk test
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696370
|Contact: Perry M Elliott, MBBS MD||020 3456 email@example.com|
|Contact: Caroline J Coats, MBBS||020 3456 firstname.lastname@example.org|
|The Heart Hospital, UCLH||Recruiting|
|London, United Kingdom, W1G 8PH|
|Principal Investigator:||Perry M Elliott, MBBS MD||University College, London|