PRE clinical mutation CARriers from families with DIlated cardiomyopathy and ACE inhibitors (PRECARDIA-INHERITANCE study)Preventive effect of ACE inhibitor (perindopril) on the onset or progression of left ventricular dysfunction in subjects at a preclinical stage from families with dilated cardiomyopathy
- Conditions
- dilated cardiomyopathyMedDRA version: 14.0Level: LLTClassification code 10056419Term: Dilated cardiomyopathySystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2010-023184-18-ES
- Lead Sponsor
- Inserm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
- adults: 18-60 years
- carriers of the mutation has been identified in the family as associated wit 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 <55%, as assessed on echocardiography
- able to provide informed consent and signed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
* Subject < 18 years old or > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>- 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<br>magnetic resonance imaging (MRI): 3 years
- Secondary Outcome Measures
Name Time Method