Status:
COMPLETED
Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Fédération Française de Cardiologie
Fondation Bordeaux Université
Conditions:
Hypertrophic Cardiomyopathy
Endothelial Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Left ventricular obstruction is an invalidating complication of hypertrophic cardiomyopathies (HCM), and endothelial dysfunction has also been observed in these pathologies. However, the relation betw...
Detailed Description
Hypertrophic cardiomyopathies (HCM) secondary to sarcomeric gene mutation or to Anderson-Fabry disease can be complicated by left ventricular (LV) outflow-tract obstruction responsible of disabling ex...
Eligibility Criteria
Inclusion
- Patients and volunteers:
- Adults (age ≥18 years), male or female,
- For female in age, efficient contraception will be required and a negative pregnancy test will be required,
- Signed informed consent form will required for each included subject after having read the information note,
- Affiliated to the national social security system,
- Patients:
- .Patients diagnosed to have HCM secondary to sarcomeric mutation or to Fabry disease, symptomatic (dyspnea on exertion and/or chest pains during exercise),
- Healthy volunteers:
- Subjects without known cardiac disease,
- No smokers.
Exclusion
- Patients and volunteers:
- No cardiac pathology reducing life expectancy to less than 12 months (cancer),
- Unbalanced arterial hypertension (systolic \>160 mmHg and/or diastolic \>120 mmHg),
- Pregnancy or breastfeeding,
- Major obesity \> 140 kg,
- Impossibility or refusal to give or sign the consent form,
- Subject in period of exclusion relative to an other protocol,
- Subject deprived of liberty by judicial or administrative decision,
- Major protected by the Law
- Patients:
- Atrial fibrillation at the time of inclusion
- Valvulopathy with severity greater than moderate.
Key Trial Info
Start Date :
October 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04129905
Start Date
October 22 2019
End Date
December 14 2021
Last Update
February 22 2022
Active Locations (1)
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1
University Hospital, Bordeaux
Pessac, France, 33604