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Trimetazidine Therapy in Hypertrophic Cardiomyopathy

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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2012
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Peak oxygen consumption [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Left ventricular function [ Time Frame: 3 months ]
    TDI and 2D strain

  2. Symptom status [ Time Frame: 3 months ]
    questionnaire

  3. Arrhythmia [ Time Frame: 3 months ]
    24 Hour Holter

  4. Cardiac biomarkers [ Time Frame: 3 months ]
  5. Exercise capacity [ Time Frame: 3 months ]
    6 minute walk test


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696370


Contacts
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

Locations
United Kingdom
The Heart Hospital, UCLH Recruiting
London, United Kingdom, W1G 8PH
Sponsors and Collaborators
University College, London
British Heart Foundation
Investigators
Principal Investigator: Perry M Elliott, MBBS MD University College, London
More Information

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01696370     History of Changes
Other Study ID Numbers: 10/0216
First Posted: October 1, 2012    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: August 2011

Keywords provided by University College, London:
Trimetazidine

Additional relevant MeSH terms:
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Trimetazidine
Vasodilator Agents