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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
  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

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Peak oxygen consumption [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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:
Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Pathological Conditions, Anatomical
Trimetazidine
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014