Dilated Cardiomyopathy Clinical Trial
Official title:
Preventive Effect of ACE Inhibitor Perindopril)on the Onset or Progression of Left Ventricular Dysfoction in Subjects at a Preclinical Stage From Families With Dilated Cardiomyopathy
This is a multicentre European double-blind,randomized and controlled trial with 2 parallel
groups (1 study medication, 1 placebo) in order to analyse the impact of ACE inhibitors
(ACEi) in subjects who carry a mutation but have not yet developed DCM (dilated
cardiomyopathy).
Objective of the trial: Study the impact of ACE inhibitors (ACEi) in subjects who carry a
mutation (leading to a genetic form of heart failure) but have not yet developed DCM.
Context. Dilated Cardiomyopathy (DCM) is one of the leading causes of Heart Failure due to
systolic dysfunction and at least 30% of DCM are of familial/genetic origin, usually with
autosomal dominant inheritance, and underlying genes and mutations are increasingly
identified. Familial Dilated Cardiomyopathy (fDCM) is characterized by age-related
penetrance (or delayed-onset), that means that the cardiac expression of the disease
(echocardiographic abnormalities) is usually absent for a long period and progressively
appears with advanced age, usually after 20 years of age
Hypothesis : ACEi may delay or prevent the occurrence of DCM in these subjects (pre-clinical
stage).
Expected results: If the hypothesis is confirmed, and as a consequence, the knowledge
derived from basic research (genes identification in DCM) will be translated into clinical
practice (early identification of subjects at high risk of developing heart failure through
predictive genetic testing) with the development of new therapeutic management (early ACEi)
that will help to decrease the morbidity and mortality associated with the disease. This
will constitute a paradigm of the development of preventive medicine thanks to the
development of genetics in the cardiovascular field.
Subjects who are concerned are ≥18 years of age and ≤60 years, carry a mutation responsible
for DCM and are at a preclinical stage of the disease. Total duration of treatment
(perindopril versus placebo) is 3 years. A total number of 200 participants will be enrolled
(100 in each group) in 7 centres.
This study is part of a broader research program, "INHERITANCE" (INtegrated HEart Research
In TrANslational genetics of dilated Cardiomyopathies in Europe) research project, submitted
to EU (FP7 European Union, HEALTH-2009-2.4.2-3: Translation of basic knowledge on inherited
cardiomyopathies into clinical practice) and accepted in 2009 (Grant agreement n° 241924,
global coordinator: Pr Eloisa Arbustini, Pavia, Italy).
- Precardia / clinical trial Principal Investigator: Dr Philippe Charron, Pitié
Salpêtrière hospital, France
- FP7 Global Inheritance network coordinator: Pr Eloisa Arbustini, Italia
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|
||
Recruiting |
NCT04982081 -
Treating Congestive HF With hiPSC-CMs Through Endocardial Injection
|
Phase 1 | |
Not yet recruiting |
NCT04703751 -
Evaluation of the CIRCULATE Catheter for Transcoronary Administration of Pharmacologic and Cell-based Agents
|
N/A | |
Recruiting |
NCT01157299 -
Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO
|
N/A | |
Completed |
NCT00765518 -
Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM)
|
Phase 2 | |
Completed |
NCT02115581 -
Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy
|
Phase 4 | |
Recruiting |
NCT04246450 -
Arrhythmic Risk Stratification in Nonischemic Dilated Cardiomyopathy
|
N/A | |
Recruiting |
NCT05799833 -
Low QRS Voltages in Young Healthy Individuals and Athletes
|
||
Recruiting |
NCT01914081 -
Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside
|
Phase 3 | |
Recruiting |
NCT03061994 -
Metabolomic Study of All-age Cardiomyopathy
|
N/A | |
Recruiting |
NCT02915718 -
A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy
|
N/A | |
Completed |
NCT03893760 -
Assessment of Right Ventricular Function in Advanced Heart Failure
|
||
Not yet recruiting |
NCT01219452 -
Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy
|
Phase 1/Phase 2 | |
Recruiting |
NCT02175836 -
Arrhythmia Prediction Trial
|
N/A | |
Active, not recruiting |
NCT00962364 -
Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease
|
||
Recruiting |
NCT05026112 -
The Arrhythmogenic Potential of Midwall Septal Fibrosis in Dilated Cardiomyopathy
|
||
Recruiting |
NCT05237323 -
Micophenolate Mofetil Versus Azathioprine in Myocarditis
|
Phase 3 | |
Recruiting |
NCT04649034 -
Intraventricular Stasis In Cardiovascular Disease
|
||
Suspended |
NCT03071653 -
Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study
|
Phase 2 | |
Completed |
NCT02619825 -
Non-Invasive Evaluation of Myocardial Stiffness by Elastography in Pediatric Cardiology (Elasto-Pédiatrie)
|
N/A |