NCT02590809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2016

Completed
Last Updated

February 10, 2022

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

October 27, 2015

Last Update Submit

February 9, 2022

Conditions

Hypertrophic Cardiomyopathy

Keywords

Left ventricular obstruction

Outcome Measures

Primary Outcomes (1)

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

    In meters

    Day 15

Secondary Outcomes (2)

  • Covered distance during the 6 minutes walk distance test (6MWT)

    Day 30

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

    Day 1, day 15, day 30

Study Arms (2)

Treatment group

EXPERIMENTAL

20 patients

Drug: Treatment BX1514MOther: Walk distance testOther: Exercise echocardiography

Placebo group

PLACEBO COMPARATOR

20 patients

Drug: PlaceboOther: Walk distance testOther: Exercise echocardiography

Interventions

Treatment BX1514MDRUG

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.

Treatment group
PlaceboDRUG

Placebo will be given for 30 days

Placebo group
Walk distance testOTHER

Walk distance test during 6 minutes

Placebo groupTreatment group
Exercise echocardiographyOTHER
Placebo groupTreatment group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • Stéphane LAFITTE, Pr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 29, 2015

Study Start

October 7, 2015

Primary Completion

July 6, 2016

Study Completion

July 6, 2016

Last Updated

February 10, 2022

Record last verified: 2017-02

Locations

FR(1)