Endothelial Dysfunction Clinical Trial
— HCM-VeinOfficial title:
Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies
Verified date | February 2022 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Left ventricular obstruction is an invalidating complication of hypertrophic cardiomyopathies (HCM), and endothelial dysfunction has also been observed in these pathologies. However, the relation between obstruction and endothelial and venous dysfunctions has not been previously studied. The main objective is to investigate the relations between endothelial and venous dysfunctions and symptomatic left ventricular outflow-tract obstruction in HCM patients.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 14, 2021 |
Est. primary completion date | December 14, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
France | University Hospital, Bordeaux | Pessac |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | Amicus Therapeutics, Fédération Française de Cardiologie, Fondation Bordeaux Université |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of the venous ejection fraction | Via a plethysmography exam. The venous ejection fraction is measured in percentage. | Day 0 | |
Primary | Assessment of the caliber variation of the brachial artery | Via a recording of arterial Doppler echography with analysis of FMD parameters. This parameter is measured in percentage. | Day 0 | |
Primary | Measure of the Willebrand factor | The analysis of this biomarker of endothelial function is performed via a peripheral venous sample.
This biomarker is measured in percentage. |
Day 0 |
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