Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy

NCT03846297 | Recruiting

• 1 other identifier: AOR17412
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to improve implantable cardioverter defibrillator (ICD) implantation decision-making processing relevance by developing a new prediction model of sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM), including newly identified potential biomarkers by magnetic resonance imaging (MRI) and genetics, through a prospective nationwide study, multivariate analysis and modelling of an absolute risk. The secondary objective is to perform a medico-economic analysis of ICD implantation in order to define an optimal rule for ICD implantation in patients with HCM, taking into account the benefits of ICD, adverse effects of ICD and associated costs (cost of quality adjusted life years saved).

Conditions

Hypertrophic Cardiomyopathy

Keywords

hypertrophic cardiomyopathy; implantable cardioverter defibrillator

Outcome Measures

Primary Outcomes (1)

• Improvement of the ability to predict major clinical events: C-index comparisons

  Comparisons of the C-index obtained between with the new score and with the different existing scores or algorithms of actual processing used for ICD decision-making. C-index is a discrimination index, which will be determined after multivariate analyses and score modeling, in the case of the new score. This evaluate of the improvement of the ability to predict major clinical events during follow-up will toward to development of a new prediction model in patients with HCM in responding the main objective of the study. Data will be collected are: (composite end point): SCD, aborted sudden death, appropriate therapy of ICD that is a physiological equivalent of SCD.

  throughout of the study, an average of 1 year

Secondary Outcomes (4)

• Cost-effectiveness study

  throughout of the study, an average of 1 year

• Cost-utility analysis

  throughout of the study, an average of 1 year

• Quality Adjusted Life Years

  at baseline and at 6-year follow-up

• Improvement of the ability to predict major clinical events: C-index comparisons

  at baseline

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Inclusion of adults with HCM, as well as teenagers 16 or older since SCD occurs frequently in this age group * Necessary not to include specific etiologies such as amyloidosis because of a known different prognosis and natural history * Necessary not to include patients with ICD as secondary prevention because of a different prognosis and a worldwide consensus on the need for ICD implantation in this case * Necessary to include all cases whatever their date of diagnosis as the predictive modelling (primary objective) targets the actual population being followed up in real life, and will ultimately be applied on this population

You may qualify if:

• Patient with a diagnosis of HCM based on conventional criteria (left ventricle wall thickness ≥ 15 mm in adult index or ≥ 13 mm in adult relatives) in the absence of abnormal loading conditions
• Aged ≥ 16 years
• Patient without or with a defibrillator (in this latter case it should have been implanted for primary prevention, not for secondary prevention)
• Affiliation to a social security insurance

You may not qualify if:

• Specific etiologies such as amyloidosis
• Patients with ICD as secondary prevention (after aborted SCD or sustained ventricular arrhythmia)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Centre de référence pour les cardiomyopathies et les troubles du rythme héréditaires ou rares - UF de Génétique, Hôpital Ambroise Paré,

Boulogne-Billancourt, Hauts-de-Seine, 92100, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample of 30 ml will be collected at baseline.

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Philippe CHARRON, MD, PhD

  Centre de référence maladies cardiaques héréditaires, Hôpital Ambroise Paré & Hôpital Pitié-Salpêtrière

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe CHARRON, MD, PhD

CONTACT

+ 33 1 49 09 55 43; philippe.charron@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 19, 2019
• Study Start: September 23, 2020
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)