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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04129905
Date of registration: 12/06/2019
Prospective Registration: Yes
Primary sponsor: University Hospital, Bordeaux
Public title: Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies HCM-Vein
Scientific title: Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies
Date of first enrolment: October 21, 2019
Target sample size: 40
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT04129905
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Patricia REANT, MD
Address: 
Telephone: (0)5 57 65 64 85
Email: patricia.reant@chu-bordeaux.fr
Affiliation: 
Name:     Patricia REANT, MD
Address: 
Telephone: (0)5 57 65 64 85
Email: patricia.reant@chu-bordeaux.fr
Affiliation: 
Name:     Patricia REANT, MD
Address: 
Telephone:
Email:
Affiliation:  University Hospital, Bordeaux
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Endothelial Dysfunction
Hypertrophic Cardiomyopathy
Intervention(s)
Biological: BNP blood sample test
Biological: Endothelial function biomarkers
Diagnostic Test: Air venous plethysmography
Diagnostic Test: Echocardiography
Diagnostic Test: Electrocardiogram
Diagnostic Test: Holter ECG
Diagnostic Test: Upper member arterial Doppler echography with analysis of FMD
Primary Outcome(s)
Assessment of the caliber variation of the brachial artery [Time Frame: Day 0]
Assessment of the venous ejection fraction [Time Frame: Day 0]
Measure of the Willebrand factor [Time Frame: Day 0]
Secondary Outcome(s)
Secondary ID(s)
CHUBX 2018/14
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Amicus Therapeutics
Fédération Française de Cardiologie
Fondation Bordeaux Université
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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