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Hypertrophic Cardiomyopathy Symptom Release by BX1514M (Light-CARMIDO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02590809
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Hypertrophic Cardiomyopathy Drug: Treatment BX1514M Drug: Placebo Other: Walk distance test Other: Exercise echocardiography Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : October 7, 2015
Actual Primary Completion Date : July 6, 2016
Actual Study Completion Date : July 6, 2016


Arm Intervention/treatment
Experimental: Treatment group
20 patients
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.

Other: Walk distance test
Walk distance test during 6 minutes

Other: Exercise echocardiography
Placebo Comparator: Placebo group
20 patients
Drug: Placebo
Placebo will be given for 30 days

Other: Walk distance test
Walk distance test during 6 minutes

Other: Exercise echocardiography



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590809


Locations
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France
CHU de Bordeaux
Bordeaux, France
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Stéphane LAFITTE, Pr University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02590809    
Other Study ID Numbers: CHUBX 2015/14
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Keywords provided by University Hospital, Bordeaux:
Left ventricular obstruction
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases