Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies
HCM-Vein
1 other identifier
interventional
40
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2019
CompletedFirst Posted
Study publicly available on registry
October 17, 2019
CompletedStudy Start
First participant enrolled
October 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2021
CompletedFebruary 22, 2022
February 1, 2022
2.1 years
June 12, 2019
February 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Assessment of the venous ejection fraction
Via a plethysmography exam. The venous ejection fraction is measured in percentage.
Day 0
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
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
Study Arms (2)
Symptomatic HCM patients
EXPERIMENTAL30 subjects (25-26 sarcomeric, 4-5 Fabry).
Healthy controls subjects
ACTIVE COMPARATOR10 subjects (matched in age and sex to HCM patients) to obtain reference values of endothelial dysfunction.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 deprived of liberty by judicial or administrative decision,
- Major protected by the Law
- Patients:
- Valvulopathy with severity greater than moderate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Bordeauxlead
- Fédération Française de Cardiologiecollaborator
- Fondation Bordeaux Universitécollaborator
- Amicus Therapeuticscollaborator
Study Sites (1)
University Hospital, Bordeaux
Pessac, 33604, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia REANT, MD
University Hospital, Bordeaux
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2019
First Posted
October 17, 2019
Study Start
October 22, 2019
Primary Completion
December 14, 2021
Study Completion
December 14, 2021
Last Updated
February 22, 2022
Record last verified: 2022-02