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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: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02590809
Date of registration: 27/10/2015
Prospective Registration: Yes
Primary sponsor: University Hospital, Bordeaux
Public title: Hypertrophic Cardiomyopathy Symptom Release by BX1514M Light-CARMIDO
Scientific title:
Date of first enrolment: October 7, 2015
Target sample size: 38
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02590809
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 2
Countries of recruitment
France
Contacts
Name:     St├ęphane LAFITTE, Pr
Address: 
Telephone:
Email:
Affiliation:  University Hospital, Bordeaux
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with a typical or atypical hypertrophic cardiomyopathy (HCM) confirmed by
imaging modalities (echo and MRI) and/or genetic tests or a relative history of HCM

- Left ventricular obstruction during exercise on treadmill (above 50 mmHg)

- Positive response to leg lifting test (obstruction reduction above 20 mmHg) at rest or
in early recovery phase

- Daily symptoms as shortness of breath during exercise (NYHA2-3), non coronary chest
pain, dizziness

- Correct ultrasound windows quality

- Sinus rhythm

- Optimal medical treatment

- For women, pregnancy test or contraception

- Written consent form obtained

Exclusion Criteria:

- Previous treatment by BX1514M

- Extra-cardiac pathology with life expectancy below than 1 year

- No capability of consent form written

- Pregnancy women

- Secondary hypertension hypertrophy, secondary valvular disease hypertrophy

- Permanent atrial fibrillation

- Severe ventricular arrhythmia without Implantable Cardioverter Defibrillator (ICD)

- Severe coronary disease

- Severe non stabilized hypertension

- Severe cardiopathy (ejection fraction below 40% or demonstrated elevated end diastolic
pressure or pulmonary pressure above 60 mmHg)

- Bradycardia

- Narrow angle glaucoma

- Vascular prethrombotic diseases

- Vascular spams

- Thyrotoxicosis

- Pheochromocytoma

- Severe renal failure (<30ml/mn)

- Patients at risk of urinary retention secondary to prostatic severe disease

- Raynaud's disease

- Non selective Monoamine Oxidase Inhibitors (MAOIs), iproniazid, nialamide or
ephedrine, methylphenidate, phenylephrine, pseudoephedrine or digitalic

- Procedures modifying the peripheral venous return

- Participation to other research protocol



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Hypertrophic Cardiomyopathy
Intervention(s)
Drug: Placebo
Drug: Treatment BX1514M
Other: Exercise echocardiography
Other: Walk distance test
Primary Outcome(s)
Change from baseline at day 15 of covered distance during the 6 minutes walk distance test (6MWT) [Time Frame: Day 15]
Secondary Outcome(s)
Covered distance during the 6 minutes walk distance test (6MWT) [Time Frame: Day 30]
Exercise echocardiography with measures of blood pressures in the rest and in the effort [Time Frame: Day 1, day 15, day 30]
Secondary ID(s)
CHUBX 2015/14
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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