Hypertrophic Cardiomyopathy Symptom Release by BX1514M

Hypertrophic Cardiomyopathy Clinical Trial

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Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590809
• Other study ID #: CHUBX 2015/14
• Status: Completed
• Phase: Phase 2
• Start date: October 7, 2015
• Est. completion date: July 6, 2016

Study information

• Verified date: February 2017
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 6, 2016
• Est. primary completion date: July 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

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.
• Placebo
Placebo will be given for 30 days

Other:
• Walk distance test
Walk distance test during 6 minutes
• Exercise echocardiography

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline at day 15 of covered distance during the 6 minutes walk distance test (6MWT)	In meters	Day 15
Secondary	Covered distance during the 6 minutes walk distance test (6MWT)	In meters	Day 30
Secondary	Exercise echocardiography with measures of blood pressures in the rest and in the effort		Day 1, day 15, day 30