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
Conditions
Interventions
Trade Name: Vastarel 20mg film coated tablets
Product Name: Trimetazidine Dihydrochloride 20mg
Product Code: not applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: trimetazidine dihydrochlori
Sponsors
University College London (UCL)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Non-obstructive hypertrophic cardiomyopathy (gradient =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: Secondary question: 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
| Measure | Time frame |
|---|---|
| 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). ;Timepoint(s) of evaluation of this end point: After 3 months treatment | — |
Countries
United Kingdom
Outcome results
None listed