Trimetazidine therapy in Hypertrophic Cardiomyopathy

Conditions: Hypertrophic cardiomyopathy (non-obstructive)
MedDRA version: 16.1Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-000038-12-GB

Lead Sponsor: niversity College London (UCL)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Principle question:<br>Does trimetazidine improve exercise capacity in patients with HCM? <br><br>We will test trimetazidine against placebo (dummy drug) in patients who have symptoms despite standard treatment. <br>;Secondary Objective: Secondary question:<br>Does trimetazidine improve quality of life, heart pump function and heart rhythm problems in patients with HCM?;Primary end point(s): Peak oxygen consumption (peak VO2);Timepoint(s) of evaluation of this end point: After 3 months treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • 6 minute walk distance<br>• Number of ventricular ectopics as determined by 24 h Holter,<br>• Minnesota Heart Failure score<br>• Echo (ejection fraction %, category of diastolic dysfunction. left atrial area, global systolic strain)<br>• Lab tests (NT pro BNP, Troponin T, Insulin/Glucose ratio)<br>• Sub maximal exercise parameters (VE/VO2 slope, VO2/work slope, VE/VCO2).<br>;Timepoint(s) of evaluation of this end point: After 3 months treatment