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Hypertrophic Cardiomyopathy Symptom Release by BX1514M (Light-CARMIDO)

Primary Purpose

Hypertrophic Cardiomyopathy

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Treatment BX1514M
Placebo
Walk distance test
Exercise echocardiography
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Cardiomyopathy focused on measuring Left ventricular obstruction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Placebo group

Arm Description

20 patients

20 patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Covered distance during the 6 minutes walk distance test (6MWT)
In meters
Exercise echocardiography with measures of blood pressures in the rest and in the effort

Full Information

First Posted
October 27, 2015
Last Updated
February 9, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT02590809
Brief Title
Hypertrophic Cardiomyopathy Symptom Release by BX1514M
Acronym
Light-CARMIDO
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 7, 2015 (Actual)
Primary Completion Date
July 6, 2016 (Actual)
Study Completion Date
July 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy
Keywords
Left ventricular obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
20 patients
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
20 patients
Intervention Type
Drug
Intervention Name(s)
Treatment BX1514M
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Placebo will be given for 30 days
Intervention Type
Other
Intervention Name(s)
Walk distance test
Intervention Description
Walk distance test during 6 minutes
Intervention Type
Other
Intervention Name(s)
Exercise echocardiography
Primary Outcome Measure Information:
Title
Change from baseline at day 15 of covered distance during the 6 minutes walk distance test (6MWT)
Description
In meters
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Covered distance during the 6 minutes walk distance test (6MWT)
Description
In meters
Time Frame
Day 30
Title
Exercise echocardiography with measures of blood pressures in the rest and in the effort
Time Frame
Day 1, day 15, day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane LAFITTE, Pr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France

12. IPD Sharing Statement

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Hypertrophic Cardiomyopathy Symptom Release by BX1514M

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