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OpenTrials
Completed

NCT Number: NCT02590809

Hypertrophic Cardiomyopathy Symptom Release by BX1514M

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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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Bordeaux

Bordeaux, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Drug

Placebo will be given for 30 days

Walk distance test

Other

Walk distance test during 6 minutes

Exercise echocardiography

Other

Primary outcomes

  1. Change from baseline at day 15 of covered distance during the 6 minutes walk distance test (6MWT)

    Time frame: Day 15

    In meters

Secondary outcomes

  1. Covered distance during the 6 minutes walk distance test (6MWT)

    Time frame: Day 30

    In meters

  2. Exercise echocardiography with measures of blood pressures in the rest and in the effort

    Time frame: Day 1, day 15, day 30

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: Light-CARMIDO

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 29, 2015
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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