NCT02590809

Hypertrophic Cardiomyopathy Symptom Release by BX1514M

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Treatment BX1514M	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.
DRUG	Placebo	Placebo will be given for 30 days
OTHER	Walk distance test	Walk distance test during 6 minutes
OTHER	Exercise echocardiography

Timeline

• Start date: 2015-10-07
• Primary completion: 2016-07-06
• Completion: 2016-07-06
• First posted: 2015-10-29
• Last updated: 2022-02-10

Locations

1 site across 1 country: France