Clinical Trials Logo

Clinical Trial Summary

Dilated cardiomyopathy (DCM) is the most common childhood cardiomyopathy and is associated with significant early morbidity and mortality. About half of patients die or require heart transplantation within 5 years of diagnosis. The medical therapy for DCM with heart failure includes anti-congestive medications and antiplatelet therapy. Those who fail to improve within the first year of diagnosis usually deteriorated even upon aggressive anti-congestive medications. The investigators had conducted precision-medicine-based approach to provide strategic approach as drug repurposing to identify new treatments. The investigators have identified the beneficial effects from a statin, simvastatin, to restore the cardiac contractility. The investigators would further assess the efficacy of simvastatin to improve the cardiac function in patients with DCM.


Clinical Trial Description

Dilated cardiomyopathy (DCM) is the most common childhood cardiomyopathy and is associated with significant early morbidity and mortality. About half of patients die or require heart transplantation within 5 years of diagnosis. The survival advantage from transplantation is limited, particularly in DCM infants. The medical therapy for DCM with heart failure includes anti-congestive medications and antiplatelet therapy. Those who fail to improve within the first year of diagnosis usually deteriorated even upon aggressive anti-congestive medications. The investigators had conducted precision-medicine-based approach to provide strategic approach as drug repurposing to identify new treatments. The investigators have identified the beneficial effects from a statin, simvastatin, to restore the cardiac contractility in a DCM proband.The initial experience in the proband is promising. Simvastatin is effective in lowing LDL and cholesterol, thereby to improve the outcome of patients with coronary arterial disease, familiar hypercholesterolemia, etc. For children, though the dosage range and the indication remain unclear, it had been used in children with various diseases. Simvastatin had been given in a small cohort of adult DCM. Patients treated with simvastatin had a lower New York Heart Association functional class compared with those receiving placebo. The LVEF also improved in the simvastatin group. The investigators would further assess the efficacy of simvastatin to improve the cardiac function in patients with DCM. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03775070
Study type Interventional
Source National Taiwan University Hospital
Contact
Status Completed
Phase Phase 2
Start date January 17, 2019
Completion date July 31, 2022

See also
  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