Hypertrophic Cardiomyopathy Clinical Trial
— OPTIM-HCMOfficial title:
Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
NCT number | NCT03846297 |
Other study ID # | AOR17412 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 23, 2020 |
Est. completion date | March 2027 |
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).
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | March 2027 |
Est. primary completion date | March 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Specific etiologies such as amyloidosis - Patients with ICD as secondary prevention (after aborted SCD or sustained ventricular arrhythmia) |
Country | Name | City | State |
---|---|---|---|
France | 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 |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Cost-effectiveness study | To determine incremental cost-effectiveness ratio (ICER) of ICD decision, in order to assess the economic impact of defibrillator implantation as a function of the chosen rule for device implantation.
Data will be collected are: direct costs (health insurance tariffs) of defibrillators, cost of their maintenance and for management of side effects, for the treatment of sudden death recovered, the medical transport, hospitalizations and for cardiology acts. |
throughout of the study, an average of 1 year | |
Secondary | Cost-utility analysis | To determine incremental cost-utility ratio of ICD decision, in order to assess the economic impact of defibrillator implantation as a function of the chosen rule for device implantation.
Data will be collected are: direct costs (health insurance tariffs) of defibrillators, cost of their maintenance and for management of side effects, for the treatment of sudden death recovered, the medical transport, hospitalizations and for cardiology acts. |
throughout of the study, an average of 1 year | |
Secondary | Quality Adjusted Life Years | QALYs calculated using EQ-5d Index:
"EQ5D-5L QoL questionnaire", a questionnaire established by EuroQol Group in 5 dimensions with 5 levers. |
at baseline and at 6-year follow-up | |
Secondary | Improvement of the ability to predict major clinical events: C-index comparisons | Comparison of the C-index obtained between the new score developed for the primary objective and the C-index obtained when the following additional covariates are added to the multivariate predictive model: gender, maximum left ventricle wall thickness obtained by MRI, left atrial volume on echocardiography, left ventricle strain on echocardiography. | at baseline |
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