Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies

NCT04129905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-02-22

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

BNP blood sample test

Performed during normal recommended follow-up of the HCM patients.

DIAGNOSTIC_TEST

Electrocardiogram

Performed during normal recommended follow-up of the HCM patients.

DIAGNOSTIC_TEST

Holter ECG

Performed during normal recommended follow-up of the HCM patients.

DIAGNOSTIC_TEST

Echocardiography

Performed during normal recommended follow-up of the HCM patients. Echocardiography at rest and during exercise.

DIAGNOSTIC_TEST

Air venous plethysmography

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.

DIAGNOSTIC_TEST

Upper member arterial Doppler echography with analysis of FMD

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.

BIOLOGICAL

Endothelial function biomarkers

Performed specifically for the research. Blood sample test, 5 minutes.

Sponsors & Collaborators

  • Fédération Française de Cardiologie

    collaborator OTHER
  • Fondation Bordeaux Université

    collaborator UNKNOWN
  • Amicus Therapeutics

    collaborator INDUSTRY
  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Patricia REANT, MD · University Hospital, Bordeaux

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-22
Primary Completion
2021-12-14
Completion
2021-12-14

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04129905 on ClinicalTrials.gov