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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 March 2022 |
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Main ID: |
NCT04129905 |
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Date of registration:
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12/06/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies
HCM-Vein |
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Scientific title:
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Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies |
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Date of first enrolment:
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October 22, 2019 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04129905 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Patricia REANT, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Bordeaux |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Endothelial Dysfunction
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Hypertrophic Cardiomyopathy
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Intervention(s)
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Diagnostic Test: Echocardiography
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Biological: Endothelial function biomarkers
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Diagnostic Test: Air venous plethysmography
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Diagnostic Test: Electrocardiogram
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Diagnostic Test: Upper member arterial Doppler echography with analysis of FMD
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Biological: BNP blood sample test
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Diagnostic Test: Holter ECG
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Primary Outcome(s)
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Measure of the Willebrand factor
[Time Frame: Day 0]
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Assessment of the venous ejection fraction
[Time Frame: Day 0]
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Assessment of the caliber variation of the brachial artery
[Time Frame: Day 0]
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Secondary ID(s)
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CHUBX 2018/04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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