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Hypertrophic CardiomyopathyPhase 2Light-CARMIDONCT02590809

Hypertrophic Cardiomyopathy Symptom Release by BX1514M

A Phase 2 study testing Treatment BX1514M, Walk distance test and Exercise echocardiography in people with Hypertrophic Cardiomyopathy, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypertrophic Cardiomyopathy
What is being tested?
Treatment BX1514M, Walk distance test and Exercise echocardiography
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteFrance
Study dates
7 Oct 2015to 6 Jul 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Optimal medical treatment
  • For women, pregnancy test or contraception
  • Written consent form obtained

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Bordeaux

    Bordeaux

Other trials in France

About this study

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.

Being tested
Treatment BX1514M, Placebo, Walk distance test, Exercise echocardiography
Keywords
Left ventricular obstruction
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • PlaceboDrug

    Placebo will be given for 30 days

  • Walk distance testOther

    Walk distance test during 6 minutes

  • Exercise echocardiographyOther

Study groups in NCT02590809
Study groupRoleWhat they receive
Treatment groupExperimental20 patients
Receives: Drug: Treatment BX1514M; Other: Walk distance test; Other: Exercise echocardiography
Placebo groupPlacebo comparator20 patients
Receives: Drug: Placebo; Other: Walk distance test; Other: Exercise echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    In meters

    Measured: Day 15

Secondary outcomes (2)

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

    In meters

    Measured: Day 30

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

    Measured: Day 1, day 15, day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2015 (estimated)
  2. Study start7 Oct 2015
  3. Primary completion6 Jul 2016
  4. Study completion6 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02590809
Sponsor's protocol ID
CHUBX 2015/14
Acronym
Light-CARMIDO
Status last verified
Feb 2017
First submitted
27 Oct 2015
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Lafitte S, Peyrou J, Reynaud A, Dijos M, Cornolle C, Roudaut R, Touche C, Ritter P, Reant P. Midodrine hydrochloride and unexpected improvement in hypertrophic cardiomyopathy symptoms. Arch Cardiovasc Dis. 2016 Mar;109(3):223-5. doi: 10.1016/j.acvd.2015.11.005. Epub 2016 Feb 15. No abstract available.

    PubMed 26898633

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Treatment BX1514M, Walk distance test and Exercise echocardiography in people with Hypertrophic Cardiomyopathy, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline at day 15 of covered distance during the 6 minutes walk distance test (6MWT) (time frame: Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02590809, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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