- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04129905
Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies (HCM-Vein)
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.
Study Overview
Status
Intervention / Treatment
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 exercise symptoms. LV outflow-tract obstruction is a complex, multifactorial and dynamical phenomenon influenced by the degree of LV hypertrophy but also by mitral valve elongation and hemodynamical components including venous return (LV preload). The clinical and research team of Dr Réant, responsible of the Bordeaux Competence Center in hereditary or rare Cardiomyopathies, has recently demonstrated that LV outflow-tract obstruction can also be influenced by the conditions of realization of exercise echocardiography tests (position: upright versus supine, type: bicycle versus treadmill), and by an abnormal venous return capacity. In parallel, it has also been demonstrated, by other research teams, that HCM can be associated to endothelial and microvascular peripheral dysfunctions. However, to date, the relation between these two elements, and with sudden cardiac death risk, have not been previously studied.
The tests which will be performed during normal recommended follow-up of the HCM patients will be: Brain Natriuretic Peptide (BNP) blood sample test, electrocardiogram (ECG), Holter ECG, echocardiography at rest and during exercise.
The tests realized in addition will be:
- air venous plethysmography: non invasive, and non painful test evaluating different parameters of venous filling by inflation of an armband around the leg, upright positioning, flexion-extension of the leg. Total duration estimated at 30-45 minutes.
- upper member arterial Doppler echography with analysis of Flow Mediated Dilatation (FMD) : measurement of the evolution of brachial artery diameter before and after inflation of a armband during 5 minutes. Non invasive and non painful test, duration 30 minutes..
- endothelial function biomarkers: blood sample test, 5 minutes. No follow-up is required for this study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pessac, France, 33604
- University Hospital, Bordeaux
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Symptomatic HCM patients
30 subjects (25-26 sarcomeric, 4-5 Fabry).
|
Performed during normal recommended follow-up of the HCM patients.
Performed during normal recommended follow-up of the HCM patients.
Performed during normal recommended follow-up of the HCM patients.
Performed during normal recommended follow-up of the HCM patients.
Echocardiography at rest and during exercise.
Performed specifically for the research.
Non invasive, and non painful test evaluating different parameters of venous filling by inflation of an armband around the leg, upright positioning, flexion-extension of the leg.
Total duration estimated at 30-45 minute.
Performed specifically for the research.
Measurement of the evolution of brachial artery diameter before and after inflation of a armband during 5 minutes.
Non invasive and non painful test, duration 30 minutes.
Performed specifically for the research.
Blood sample test, 5 minutes.
|
Active Comparator: Healthy controls subjects
10 subjects (matched in age and sex to HCM patients) to obtain reference values of endothelial dysfunction.
|
Performed specifically for the research.
Non invasive, and non painful test evaluating different parameters of venous filling by inflation of an armband around the leg, upright positioning, flexion-extension of the leg.
Total duration estimated at 30-45 minute.
Performed specifically for the research.
Measurement of the evolution of brachial artery diameter before and after inflation of a armband during 5 minutes.
Non invasive and non painful test, duration 30 minutes.
Performed specifically for the research.
Blood sample test, 5 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the venous ejection fraction
Time Frame: Day 0
|
Via a plethysmography exam.
The venous ejection fraction is measured in percentage.
|
Day 0
|
Assessment of the caliber variation of the brachial artery
Time Frame: Day 0
|
Via a recording of arterial Doppler echography with analysis of FMD parameters.
This parameter is measured in percentage.
|
Day 0
|
Measure of the Willebrand factor
Time Frame: Day 0
|
The analysis of this biomarker of endothelial function is performed via a peripheral venous sample. This biomarker is measured in percentage. |
Day 0
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patricia REANT, MD, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2018/04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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