Hypertrophic cardiomyopathy
Conditions
Interventions
Trade Name: Gutron 2,5mg
Pharmaceutical Form: Capsule
INN or Proposed INN: MIDODRINE HYDROCHLORIDE
CAS Number: 3092-17-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults aged 18-80 years of both sexes, - Patients carrying a typical or atypical hypertrophic cardiomyopathy diagnosed by cardiac imaging (echocardiography and MRI) and / or genetic testing or family history, - Obstruction per-effort treadmill (in aortic obstruction> 50 mmHg measured continuously aligned with the Doppler aortic ejection) - Positive response (=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Minor Patient, - Taking Gutron® earlier, - Extra-cardiac pathology limiting life expectancy to less than a year, - Inability to consent or refusal to sign the consent, - Pregnant and breastfeeding women, - Hypertrophy secondary to hypertensive or valvular disease, - Permanent atrial fibrillation, - Threatening ventricular rhythm disorders (ventricular doublets, bigeminy, bursts TV) without a pacemaker, - Severe Coronary Artery Disease, - Hypertension unbalanced by the usual therapeutic, - Severe heart disease (Fe 60 mmHg) - Narrow Angle Glaucoma, - Obliterative vasculopathy severe, - Vasospasm, - Thyrotoxicosis, - Pheochromocytoma, - Severe renal impairment <30ml / min, - Raynaud's disease, - History of CHD pain, - Non-selective MAO inhibitors (iproniazid, nialamide) or indirect sympathomimetic (ephedrine, methylphenidate, phenylephrine, pseudoephedrine), or digitalis, - Any procedure modifying the venous return: vein stripping / venotomy the lower limbs, - Participation in another biomedical research study, - Criteria relating to the regulation: persons under safeguard justice, physical and / or psychological severely impaired, which according to the investigator, may affect the compliance of participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of chlorydrate of midodrine effects to placebo for improving walk distance test on day 15.;Secondary Objective: analysis and comparison of LVOTO using rest and exercise echocardiography in the two groups (treatment and placebo), evolution of NYHA functional class, quality of life tests, BNP and treatment tolerance in the two groups.;Primary end point(s): Distance covered in meters during the 6-minute walk test (6MWT) at Day 15.;Timepoint(s) of evaluation of this end point: Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The distance covered in meters during the 6-minute walk test (6MWT) at D30. - The measurement of intra ventricular obstruction at rest and during exercise, Doppler evaluation of intraventricular obstruction parameter, - NYHA functional class (1-4) - The score at standardized quality of life questionnaires KCCQ and EQ5D - CCS pain score, - BNP, - The stress echocardiography with measurement of blood pressure at rest and during exercise - Safety of treatment.;Timepoint(s) of evaluation of this end point: Day 30 | — |
Countries
France
Contacts
Public ContactREC
CHU de Bordeaux
Outcome results
None listed