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 - PRECARDIA study

Inserm0 个研究点目标入组 200 人开始时间: 2011年9月8日最近更新: 2014年3月10日

适应症

试验速览

暂无简介。

•- 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 <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

发起方