Hypertrophic CARdiomyopathy symptom release by alpha stimulant MIDOdrine

• Conditions: Hypertrophic cardiomyopathy; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-003521-34-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-08
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 (<50 mmHg obstruction) test Leg-lifting of rest and / or immediate post-exercise
- Symptomatic to stress in daily life: dyspnea NYHA 2-3, non coronary chest pain, fainting effort,
- Exploitable ultrasonic window,
- Sinus rhythm,
- Optimal medical treatment,
- For women of childbearing potential, effective contraception and required negative pregnancy test,
- Intent Consent form signed by the patient after having read the information letter,
- Patient affiliated to national health system.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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 <40% or severe elevated filling pressures, pulmonary hypertension> 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): - The distance covered in meters during the 6-minute walk test (6MWT) at D30.<br>- The measurement of intra ventricular obstruction at rest and during exercise, Doppler evaluation of intraventricular obstruction parameter,<br>- NYHA functional class (1-4)<br>- The score at standardized quality of life questionnaires KCCQ and EQ5D<br>- CCS pain score,<br>- BNP,<br>- The stress echocardiography with measurement of blood pressure at rest and during exercise<br>- Safety of treatment.;Timepoint(s) of evaluation of this end point: Day 30