dilated cardiomyopathy MedDRA version: 14.0 Level: LLT Classification code 10056419 Term: Dilated cardiomyopathy System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Coversyl 5mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: peridopril arginine
Concentration number: 5 mg-
Pharmaceutical form of the placebo: Film-coated tablet
Route of ad
Sponsors
Inserm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - adults: 18-60 years - carriers of the mutation has been identified in the family as associated with DCM and who have received appropriate genetic counselling before and after the announcement of the genetic result - at least one family member should have a clinical diagnosis of dilated cardiomyopathy - no obvious DCM assessed - presence of minor LV abnormality: isolated LVEDD >112% or reduced systolic dysfunction : LVEF =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * Subject 60 years * Other disease or factor that can cause minor LV abnormalities, such as cardiotoxic treatment or significant blood hypertension (with uncontrolled blood pressure or significant hypertrophy on echocardiography). * Contraindication to ACE inhibitor (prior intolerance or adverse reaction, e.g. angio-oedeme, patients with hereditary or idiopathic angioedema, hypersensitivity to perindopril or any of the excipients (e.g. hereditary problems of galactose intolerance, glucose galactose malabsorption, or the Lapp lactase deficiency)) * Impaired renal function (serum creatinine > 150 micromol/l). * Baseline serum potassium >5.5 mmol/L. * Pregnant, parturient or breastfeeding woman or woman of childbearing potential not under effective contraception or planned pregnancy. * Participation in another therapeutic trial in the previous 3 months * Participants who are already treated with ACE inhibitor or sartan or aldosterone receptor antagonists (for various reason such as arterial hypertension) can not be included in this study, unless they have been off these drugs for a period of 6 weeks before inclusion. * Participants treated with lithium * participant under legal guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Study the impact of ACE inhibitors (ACEi) in subjects who carry a mutation but have not yet developed DCM through a double blind randomized (parallel group) multicenter trial. - to extend the medical impact of predictive genetic testing in DCM (direct therapeutic impact).;Secondary Objective: Not applicable;Primary end point(s): occurence of DCM or deterioration of LV end-diastolic diameter / volume or deterioration of Ejection fraction; all criteria determined either by Echocardiography or by magnetic resonance imaging (MRI);Timepoint(s) of evaluation of this end point: Echocardiography: 1, 2, 3 years magnetic resonance imaging (MRI): 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - echocardiographic deterioration of LVEDD or ejection fraction - MRI deterioration of LVEDVol or Ejection fraction - occurence of DCM - Deterioration of other Echocardiographic parameters: TDI velocities (average Sa & Ea velocities) at the mitral annulus (lateral and septal), and the E/Ea ratio TDI strain and strain rate (radial, longitudinal, circonferential strain rate in the basal, mid and apical segments) LV volumes (LVED Vol and LVES Vol, Simpson method, 4 cavity incidence) - Deterioration of hormonal biomarkers in serum: Natriuretic peptid: BNP and NTproBNP (+/-4% or final versus baseline). Mid-Regional pro-Adrenomedullin (MR-proADM) and Mid-Regional proANP, (+/-4% or final versus baseline) - other planned end-point but without sufficient statistical power: symptoms (dyspnoea: NYHA stage 1 to 4); hospitalisation (not planned) for heart failure); Safety end-point: nos excess of all cause death, cardiovascular death ;Timepoint(s) of evaluation of this end point: biological analysis: last visit Echocardiography: 1, 2, 3 years magnetic resonance imaging (MRI): 3 years | — |
Countries
Denmark, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Contacts
Public ContactAnne PUECH
INSERM
Outcome results
None listed