Hypertrophic Cardiomyopathy Symptom Release by BX1514M
France38 participantsStarted 2015-10-07
Plain-language summary
Hypertrophic cardiomyopathy (HCM) is the most frequent genetic cardiac disease characterized by an asymmetric hypertrophic. In two third of patients, an obstruction to blood ejection is observed within the left ventricle which is named left ventricular outflow tract obstruction (LVOTO). This phenomenon can occur at rest or during exercise and is associated with symptoms such as dyspnea, dizziness or chest pain that can significantly limit day life adaptation. To now, medical or interventional treatments such as betablocacker, calcium blockers or septal alcoholisation or surgery present with a limited efficiency. Recent studies from investigators group revealed new concepts about the role of venous return to the LVOTO. Therefore the investigators hypothesis that BX1514M generating a venous vascular constriction, could improve symptoms of HCM patients by reducing LVOTO.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 I…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline at day 15 of covered distance during the 6 minutes walk distance test (6MWT)