Hypertrophic Cardiomyopathy Symptom Release by BX1514M

NCT ID: NCT02590809

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-07
• Study Completion Date: 2016-07-06

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment group

20 patients

Group Type: EXPERIMENTAL

Treatment BX1514M

Intervention Type: 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.

Walk distance test

Intervention Type: OTHER

Walk distance test during 6 minutes

Exercise echocardiography

Intervention Type: OTHER

Placebo group

20 patients

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be given for 30 days

Walk distance test

Intervention Type: OTHER

Walk distance test during 6 minutes

Exercise echocardiography

Intervention Type: OTHER

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo will be given for 30 days

Intervention Type: DRUG

Walk distance test

Walk distance test during 6 minutes

Intervention Type: OTHER

Exercise echocardiography

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphane LAFITTE, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2015/14

Identifier Type: -

Identifier Source: org_study_id