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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 August 2015 |
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Main ID: |
EUCTR2011-000038-12-GB |
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Date of registration:
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17/08/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Trimetazidine therapy in Hypertrophic Cardiomyopathy
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Scientific title:
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A Phase 2b randomised, double blind, placebo-controlled trial of trimetazidine therapy in patients with non-obstructive hypertrophic cardiomyopathy. - Trimetazidine therapy in hypertrophic cardiomyopathy |
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Date of first enrolment:
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13/09/2011 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000038-12 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria:
• Non-obstructive hypertrophic cardiomyopathy (gradient < 50 mmHg)
• NYHA Class = 2
• Abnormal peak VO2 as % predicted for age and gender
• Age 18 years or above
• Resting heart rate < 90/minute at rest. Rhythm may be sinus rhythm (SR), atrial fibrillation (AF) or paced.
• No significant renal or hepatic impairment
• Able to comply with study requirements and able to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion criteria:
• Female participant who is pregnant, breast-feeding or planning pregnancy during the course of the study. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment.
• Significant renal (GFR <60ml/min) or hepatic impairment
• Involvement in another research study in the past 12 weeks
• Diabetes mellitus
• Known hypersensitivity to trimetazidine
• Participant has Parkinson’s disease or Parkinsonism.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Hypertrophic cardiomyopathy (non-obstructive)
MedDRA version: 16.1
Level: PT
Classification code 10020871
Term: Hypertrophic cardiomyopathy
System Organ Class: 10010331 - Congenital, familial and genetic disorders
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Intervention(s)
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Trade Name: Vastarel 20mg film coated tablets
Product Name: Trimetazidine Dihydrochloride 20mg
Product Code: not applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: trimetazidine dihydrochloride
CAS Number: 13171-25-0
Current Sponsor code: not applicable
Other descriptive name: 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: Principle question:
Does trimetazidine improve exercise capacity in patients with HCM?
We will test trimetazidine against placebo (dummy drug) in patients who have symptoms despite standard treatment.
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Primary end point(s): Peak oxygen consumption (peak VO2)
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Secondary Objective: Secondary question:
Does trimetazidine improve quality of life, heart pump function and heart rhythm problems in patients with HCM?
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Timepoint(s) of evaluation of this end point: After 3 months treatment
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Secondary Outcome(s)
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Secondary end point(s): • 6 minute walk distance
• Number of ventricular ectopics as determined by 24 h Holter,
• Minnesota Heart Failure score
• Echo (ejection fraction %, category of diastolic dysfunction. left atrial area, global systolic strain)
• Lab tests (NT pro BNP, Troponin T, Insulin/Glucose ratio)
• Sub maximal exercise parameters (VE/VO2 slope, VO2/work slope, VE/VCO2).
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Timepoint(s) of evaluation of this end point: After 3 months treatment
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Source(s) of Monetary Support
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British Heart Foundation
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UCLH/UCL NIHR Comprehensive Biomedical Research Centre
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Results
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Results available:
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Date Posted:
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Date Completed:
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