Trimetazidine Therapy in Hypertrophic Cardiomyopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University College, London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
British Heart Foundation
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01696370
First received: September 27, 2012
Last updated: February 27, 2013
Last verified: August 2011

September 27, 2012
February 27, 2013
April 2012
April 2014   (final data collection date for primary outcome measure)
Peak oxygen consumption [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01696370 on ClinicalTrials.gov Archive Site
  • 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
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
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
Both
18 Years and older
No
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
 
NCT01696370
10/0216
Yes
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