NCT02922517

Brief Summary

Fibrosis, myocardial deformation and biomarkers in hypertrophic cardiomyopathy (HCM)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

7.5 years

First QC Date

March 25, 2013

Last Update Submit

September 8, 2021

Conditions

Hypertrophic Cardiomyopathy

Keywords

biomarkersechocardiographyMRI imagingnuclear medicine

Outcome Measures

Primary Outcomes (1)

  • measurement of the overall longitudinal myocardial strain (in 2D strain)

    day 90

Secondary Outcomes (6)

  • global myocardial longitudinal deformation (three-dimensional)

    day 90

  • Transforming growth factor (TGF) blood dosage

    at year 3

  • Bone morphogenetic protein 2 (BMP2) blood dosage

    at year 3

  • Periostin blood dosage

    at year 3

  • Heart Failure Symptoms evaluation

    day 90

  • +1 more secondary outcomes

Study Arms (3)

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

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of both sex over 16 year-old with HCM

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for biomarkers assessment

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry Le Tourneau, PU-PH

CONTACT

0617908670thletourneau@yahoo.fr

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2013

First Posted

October 4, 2016

Study Start

June 1, 2014

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

FR(1)