Trimetazidine Therapy in Hypertrophic Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
British Heart Foundation
Information provided by (Responsible Party):
University College, London

September 27, 2012
October 1, 2012
February 28, 2013
April 2012
April 2014   (Final data collection date for primary outcome measure)
Peak oxygen consumption [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT01696370 on Archive Site
  • Left ventricular function [ Time Frame: 3 months ]
    TDI and 2D strain
  • Symptom status [ Time Frame: 3 months ]
  • Arrhythmia [ Time Frame: 3 months ]
    24 Hour Holter
  • Cardiac biomarkers [ Time Frame: 3 months ]
  • Exercise capacity [ Time Frame: 3 months ]
    6 minute walk test
Same as current
Not Provided
Not Provided
Trimetazidine Therapy in Hypertrophic Cardiomyopathy
A Phase 2b Randomised, Double Blind, Placebo-controlled Trial of Trimetazidine Therapy in Patients With Non-obstructive Hypertrophic Cardiomyopathy

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.


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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hypertrophic Cardiomyopathy
  • Drug: Trimetazidine
    Trimetazidine 20mg three times per day for 3 months
  • Other: Placebo capsule
    one capsule three times per day for 3 months
  • Active Comparator: Trimetazidine
    Intervention: Drug: Trimetazidine
  • Placebo Comparator: Placebo capsule
    Intervention: Other: Placebo capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
April 2014
April 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
Not Provided
University College, London
University College, London
British Heart Foundation
Principal Investigator: Perry M Elliott, MBBS MD University College, London
University College, London
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP