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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | 20 patients |
|
| Placebo group | Placebo Comparator | 20 patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment BX1514M | Drug | X mg x 3 /day of BX1514M for 15 days. Dosage will be then adapted, depending on symptoms release and walk distance test results for another 15 days period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline at day 15 of covered distance during the 6 minutes walk distance test (6MWT) | In meters | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Covered distance during the 6 minutes walk distance test (6MWT) | In meters | Day 30 |
| Exercise echocardiography with measures of blood pressures in the rest and in the effort | Day 1, day 15, day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane LAFITTE, Pr | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26898633 | Result | Lafitte S, Peyrou J, Reynaud A, Dijos M, Cornolle C, Roudaut R, Touche C, Ritter P, Reant P. Midodrine hydrochloride and unexpected improvement in hypertrophic cardiomyopathy symptoms. Arch Cardiovasc Dis. 2016 Mar;109(3):223-5. doi: 10.1016/j.acvd.2015.11.005. Epub 2016 Feb 15. No abstract available. |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| Placebo | Drug | Placebo will be given for 30 days |
|
| Walk distance test | Other | Walk distance test during 6 minutes |
|
| Exercise echocardiography | Other |
|
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |