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Predictive Factors and Consequences of Myocardial Fibrosis in Hypertrophic Cardiomyopathy (HCM)

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ClinicalTrials.gov Identifier: NCT02922517
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : September 9, 2021
Sponsor:
Collaborators:
University Hospital, Lille
Rennes University Hospital
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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Brief Summary:
Fibrosis, myocardial deformation and biomarkers in hypertrophic cardiomyopathy (HCM)

Condition or disease
Hypertrophic Cardiomyopathy

Detailed Description:

Hypertrophic cardiomyopathy (HCM) is a rare genetic disease (1), whose phenotypic expression is found in less than 1/1000 people, mainly linked to a mutation of a protein of the sarcomere (14 genes and 400 mutations identified nowadays). HCM occurs in about 50% of cases in young adults under the age of 30 years. Progress in the identification of the responsible mutation does not have allowed significant advances for the clinical management and evaluation of the prognosis of patients with HCM. In fact, the link between genotype and phenotype is poor in the HCM, so that identification of the mutation in approximately 60% of patients does not properly characterize the disease and its evolution. It is therefore necessary to identify new markers to better characterize HCM patients. Myocardial fibrosis could be a severity marker of the HCM but its consequences and determinants are little known or unknown.

The objective of this work is to identify the determinants and consequences of myocardial fibrosis in HCM, particularly the relationship between fibrosis and left ventricular dysfunction assessed by the analysis of myocardial deformation and between fibrosis and heart failure. The study of fibrosis, which concerns 30 to 70% of patients and replace 1 to 70% of the myocardial tissue, is made possible in vivo by analysis of delayed enhancement gadolinium in MRI. This work aims to study the relationship between myocardial fibrosis, heart function assessed by myocardial deformation, heart failure, and biological profile (proteomics) of patients at rest and after exertion.

This study is an observational research. Indeed, all examinations are done as part of usual care patients. Only additional tubes of blood are collected in the initial biological assessment.

Study Design
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Study Type : Observational
Estimated Enrollment : 115 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Predictive Factors and Consequences of Myocardial Fibrosis in Hypertrophic Cardiomyopathy
Actual Study Start Date : June 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Groups and Cohorts
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Group/Cohort
patients with obstructive HCM
patients with HCM (obstructive or no obstructive)
controls
patients without HCM
patients with non obstructive HCM
patients with non obstructive HCM


Outcome Measures
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Primary Outcome Measures :
  1. measurement of the overall longitudinal myocardial strain (in 2D strain) [ Time Frame: day 90 ]

Secondary Outcome Measures :
  1. global myocardial longitudinal deformation (three-dimensional) [ Time Frame: day 90 ]
  2. Transforming growth factor (TGF) blood dosage [ Time Frame: at year 3 ]
  3. Bone morphogenetic protein 2 (BMP2) blood dosage [ Time Frame: at year 3 ]
  4. Periostin blood dosage [ Time Frame: at year 3 ]
  5. Heart Failure Symptoms evaluation [ Time Frame: day 90 ]
    New York Heart Association (NYHA) stage, presence of congestive signs according to the Framingham Heart Study, functional capacity

  6. type of heart failure [ Time Frame: day 90 ]
    sub aortic obstruction if gradient rest or effort greater than or equal to 30 mmHg, left ventricle (LV) systolic dysfunction assessed on the ejection fraction (EF) less than or equal to 50%, restrictive heart disease


Biospecimen Retention:   Samples With DNA
Blood sample for biomarkers assessment

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of both sex over 16 year-old with HCM
Criteria

Inclusion Criteria:

  • Patients with known HCM or recently discovered with a wall thickness greater than or equal to15 mm without family background or> 13 mm in an HCM family context in the absence of other causes found capable of producing such a degree of hypertrophy
  • HCM apparently linked to a mutation of a protein of the sarcomere (identified mutation or absence of other causes of hypertrophy found when the mutation search was not performed or was unsuccessful)
  • Control subjects will be patients greater than or equal to 18 years without known cardiovascular disease or that may affect their ability to function, addressed to achieve a stress echocardiography for assessment of atypical symptoms, with a low pretest probability of coronary artery disease, and accepting blood sample before and after exercise. They do not realize Holter ECG or cardiac MRI as part of the study.

Exclusion Criteria:

  • Refusal of the patient
  • Age < 16 years old
  • Valvulopathy associated significant (grade 3 or 4 regurgitation, or severe stenosis) other than mitral insufficiency
  • Defibrillator, pacemaker, or other cons-indication or intolerance to achieving MRI
  • Unable to receive clear information (patient's intellectual default)
  • Under protective measure of justice
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922517


Contacts
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Contact: Thierry Le Tourneau, PU-PH 0617908670 thletourneau@yahoo.fr

Locations
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France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Thierry Le Tourneau, PU-PH    0617908670    thletourneau@yahoo.fr   
Principal Investigator: Thierry Le Tourneau, PU-PH         
Sub-Investigator: Jean-Noel Trochu, PU-PH         
Sub-Investigator: Dominique Crochet, PU-PH         
Sub-Investigator: Karine Warin, PH         
Sub-Investigator: Nicolas Piriou, PH         
Sub-Investigator: Vincent Probst, PU-PH         
Sub-Investigator: Patrice Guerin, PU-PH         
Sub-Investigator: Gilles Lande, PH         
Sub-Investigator: Aude Solnon, PH         
Sub-Investigator: Jean-Pierre Gueffet, PH         
Sponsors and Collaborators
Nantes University Hospital
University Hospital, Lille
Rennes University Hospital
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Philippe Mabo, PU-PH Rennes University Hospital
Principal Investigator: Erwan Donal, McU-PH Rennes University Hospital
Principal Investigator: Pascal de Groote, PH Lille University Hospital
Principal Investigator: Anne-Sophie Polge, PH Lille University Hospital
Principal Investigator: Marjorie Richardson, PH Lille University Hospital
Principal Investigator: Nicolas Lamblin, PH Lille University Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02922517    
Other Study ID Numbers: Prog/11/35
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Keywords provided by Nantes University Hospital:
biomarkers
echocardiography
MRI imaging
nuclear medicine
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
 Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases