Hypertrophic CardiomyopathyHCMNCT02922517
Predictive Factors and Consequences of Myocardial Fibrosis in Hypertrophic Cardiomyopathy
An observational study of Hypertrophic Cardiomyopathy, run by Nantes University Hospital at 1 site in France.
Trial summary
Fibrosis, myocardial deformation and biomarkers in hypertrophic cardiomyopathy (HCM) Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of both sex over 16 year-old with HCM
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, 44093
Thierry Le Tourneau, PU-PH, 0617908670, thletourneau@yahoo.fr
Thierry Le Tourneau, PU-PH
About this study
Fibrosis, myocardial deformation and biomarkers in hypertrophic cardiomyopathy (HCM)
Read the 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.
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- biomarkers, echocardiography, MRI imaging, nuclear medicine
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of the overall longitudinal myocardial strain (in 2D strain)
Measured: day 90
Secondary outcomes (6)
global myocardial longitudinal deformation (three-dimensional)
Measured: day 90
Transforming growth factor (TGF) blood dosage
Measured: at year 3
Bone morphogenetic protein 2 (BMP2) blood dosage
Measured: at year 3
Periostin blood dosage
Measured: at year 3
Heart Failure Symptoms evaluation
New York Heart Association (NYHA) stage, presence of congestive signs according to the Framingham Heart Study, functional capacity
Measured: day 90
type of heart failure
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
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startJun 2014
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille, Rennes University Hospital, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Philippe Mabo, PU-PH, Principal investigator, Rennes University HospitalErwan Donal, McU-PH, Principal investigator, Rennes University HospitalPascal de Groote, PH, Principal investigator, University Hospital, LilleAnne-Sophie Polge, PH, Principal investigator, University Hospital, LilleMarjorie Richardson, PH, Principal investigator, University Hospital, LilleNicolas Lamblin, PH, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922517
- Sponsor's protocol ID
- Prog/11/35
- Acronym
- HCM
- Status last verified
- Sep 2021
- First submitted
- 25 Mar 2013
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors and Consequences of Myocardial Fibrosis in Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT02922517
- Acronym / sponsor ID
- HCM / Prog/11/35
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- biomarkers, echocardiography, MRI imaging, nuclear medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Lille, Rennes University Hospital, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fibrosis, myocardial deformation and biomarkers in hypertrophic cardiomyopathy (HCM)
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
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of both sex over 16 year-old with HCM
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measurement of the overall longitudinal myocardial strain (in 2D strain)
Time frame: day 90
6 secondary outcomes
global myocardial longitudinal deformation (three-dimensional)
Time frame: day 90
Transforming growth factor (TGF) blood dosage
Time frame: at year 3
Bone morphogenetic protein 2 (BMP2) blood dosage
Time frame: at year 3
Periostin blood dosage
Time frame: at year 3
Heart Failure Symptoms evaluation
Time frame: day 90
type of heart failure
Time frame: day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Mabo, PU-PH principal investigator
Rennes University Hospital
Erwan Donal, McU-PH principal investigator
Rennes University Hospital
Pascal de Groote, PH principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thierry Le Tourneau, PU-PH (0617908670, thletourneau@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of the overall longitudinal myocardial strain (in 2D strain) (time frame: day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.