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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.
Register: EUCTR
Last refreshed on: 7 December 2015
Main ID:  EUCTR2015-003521-34-FR
Date of registration: 08/09/2015
Prospective Registration: Yes
Primary sponsor: CHU de Bordeaux
Public title: Hypertrophic CARdiomyopathy symptom release by alpha stimulant MIDOdrine
Scientific title: Hypertrophic CARdiomyopathy symptom release by alpha stimulant MIDOdrine - Light-CARMIDO
Date of first enrolment: 09/10/2015
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003521-34
Study type:  Interventional clinical trial of medicinal product
Study design:  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  
Phase: 
Countries of recruitment
France
Contacts
Name: REC   
Address:  12 rue Dubernat 33404 Talence France
Telephone: +33557821097
Email: vincent.dejarnac@chu-bordeaux.fr
Affiliation:  CHU de Bordeaux
Name: REC   
Address:  12 rue Dubernat 33404 Talence France
Telephone: +33557821097
Email: vincent.dejarnac@chu-bordeaux.fr
Affiliation:  CHU de Bordeaux
Key inclusion & exclusion 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 (<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 GutronĀ® 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Hypertrophic cardiomyopathy
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Intervention(s)

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 number: 2.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Gutron 5mg
Pharmaceutical Form: Capsule
INN or Proposed INN: MIDODRINE HYDROCHLORIDE
CAS Number: 3092-17-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: Comparison of chlorydrate of midodrine effects to placebo for improving walk distance test on day 15.
Primary end point(s): Distance covered in meters during the 6-minute walk test (6MWT) at 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.
Timepoint(s) of evaluation of this end point: Day 15
Secondary Outcome(s)
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
Secondary ID(s)
CHUBX2015/14
Source(s) of Monetary Support
CHU de Bordeaux
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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