Therapy With Verapamil or Carvedilol in Chronic Heart Failure

Learn more about:
Related Clinical Trial
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease CorCinch-HF Repair System in Patients Who Present With Symptomatic Non-Ischemic or Ischemic Dilated Cardiomyopathy Early Administration of Ivabradine in Children With Heart Failure Metabolomics and Microbiomics in Cardiovascular Diseases Mannheim TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies Risk Stratification in Children and Adolescents With Primary Cardiomyopathy Pediatric Cardiomyopathy Mutation Analysis German Centre for Cardiovascular Research Cardiomyopathy Register Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO An Integrative-“Omics” Study of Cardiomyopathy Patients for Diagnosis and Prognosis in China Metabolomic Study of All-age Cardiomyopathy Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry The Genetics of Cardiomyopathy and Heart Failure Inflammation, Cardiac Sympathetic Innervation, and Arrhythmic Sudden Death Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe Randomized Trial of Interventions to Improve Warfarin Adherence Testing Strategies to Improving Warfarin Adherence Prospective Study Looking at Quality of Life Measures in Non-ischaemic Cardiomyopathy After Mitral Valve Repair Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study The Cardiovascular Genetic and Therapeutic Implications of Muscular Dystrophy A Randomized Trial of Carvedilol in Chronic Chagas Cardiomyopathy Role of Endothelial Function, Muscular Fitness and Metabolism in Functional Activity in Patients With Chronic Heart Failure (CHF) Echo Assessment of Intraventricular Dyssynchrony Brain Function and Perfusion in Patients With Heart Failure Molecular and Imaging Studies of Cardiovascular Health and Disease Genotype-Phenotype Associations in Pediatric Cardiomyopathy (PCM GENES) Optimizing Left Ventricular Lead To Improve Cardiac Output Using Ripple Mapping to Guide Substrate Ablation of Scar Related Ventricular Tachycardia. Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491 Efficacy and Safety Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure Harefield Recovery Protocol Study for Patients With Refractory Chronic Heart Failure ACC – Atrial Contribution to CRT Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril Non-Invasive Evaluation of Myocardial Stiffness by Elastography in Pediatric Cardiology (Elasto-Pédiatrie) Manganese-Enhanced Magnetic Resonance Imaging of the Myocardium Efficacy of Implantable Cardioverter Defibrillator in Patients With Non-ischemic Systolic Heart Failure on Mortality Cardiac Biomarkers in Pediatric Cardiomyopathy (PCM Biomarkers) Arrhythmia Prediction Trial Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants A Single Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of MYK-491 Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study. Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy. A Pivotal Trial to Establish the Efficacy and Safety of Algisyl in Patients With Moderate to Severe Heart Failure Effect of Rosuvastatin on Left Ventricular Remodeling Intraventricular Stasis in Non Ischemic Dilated Myocardiopathy Assessment of Right Ventricular Function in Advanced Heart Failure An Open Label Rollover Trial for Patients Randomized to the Control Group of Study LSH-10-001 Optimized Biventricular Pacing Allograft Recipients BiPAP for Cardiomyopathy With Central Sleep Apnea Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis Effect of Aldosterone on Energy Starvation in Heart Failure Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside Therapy With Verapamil or Carvedilol in Chronic Heart Failure Effect of Beta-blockers on Structural Remodeling and Gene Expression in the Failing Human Heart Training Study to Evaluate the Benefit of Exercise for Patients With Chronic Heart Failure Danish ICD Study in Patients With Dilated Cardiomyopathy Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy DCM Precision Medicine Study A Randomized, Controlled Study to Evaluate Algisyl-LVR™ as a Method of Left Ventricular Augmentation for Heart Failure The Genetics of Dilated Cardiomyopathy: A Quebec-Based Study Potential Role of Water-soluble Ubiquinol in Complementary Therapy for Pediatric Dilated Cardiomyopathy A Trial of Autologous Bone Marrow Derived Stem Cells in Paediatric Heart Failure Resynchronization Therapy in Young Patients With and Without CHD Withdrawal of Medication in Recovered DCM Use of Bone Marrow Derived Stem Cell and G-CSF With Circulatory Assistance in the Treatment of DCM The Influence of Atorvastatin on the Parameters of Inflammation and the Function of Left Ventricle Safety and Feasibility of Algisyl-LVR™ as a Method of Left Ventricular Restoration in Patients With DCM Undergoing Open-heart Surgery PUFAs and Left Ventricular Function in Heart Failure 18F-deoxyglucose (FDG) PET-CMD Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM) Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy Combination of Olmesartan Effect on Myocardial Viability of Patients With Dilated Cardiomyopathy Mesenchymal Stem Cells for Idiopathic Dilated Cardiomyopathy Continues Positive Airway Pressure Treatment for Patients With Dilated Cardiomyopathy and Obstructive Sleep Apnea Pathophysiology of Dilated Cardiomyopathy Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy Clinical and Genetic Examinations of Dilated Cardiomyopathy Simvastatin Therapy in Patients With Dilated Cardiomyopathy. Bone Marrow Derived Adult Stem Cells for Dilated Cardiomyopathy Safety and Efficacy Study of Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy Respiratory Muscles Training in Patients With Dilated Cardiomyopathy Myocardial Metabolism in Patients With Dilated Cardiomyopathy Intracoronary Autologous Mesenchymal Stem Cells Implantation in Patients With Ischemic Dilated Cardiomyopathy Orodispersible Minitablets of Enalapril in Children With Heart Failure Due to Dilated Cardiomyopathy Multicenter Study of Immunoadsorption in Dilated Cardiomyopathy Cell Therapy In Dilated Cardiomyopathy Safety and Efficacy Study of Stem Cell Transplantation to Treat Dilated Cardiomyopathy Intracoronary Infusion of Autologous Bone Marrow Cells for Treatment of Idiopathic Dilated Cardiomyopathy Infusion Intracoronary of Mononuclear Autologous Adult no Expanded Stem Cells of Bone Marrow on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure. Nesiritide – Dilated Cardiomyopathy A Study of Impact of Anemia on Morbidity and Mortality in Children With Dilated Cardiomyopathy Defining the Role of Insulin Resistance in ‘Idiopathic’ Dilated Cardiomyopathy Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM) Use of Ixmyelocel-T (Formerly Catheter-based Cardiac Repair Cell [CRC]) Treatment in Patients With Heart Failure Due to Dilated Cardiomyopathy A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy Supramaximal Titrated Inhibition of RAAS in Dilated Cardiomyopathy Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy Honey in Idiopathic Dilated Cardiomyopathy A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

Brief Title

Therapy With Verapamil or Carvedilol in Chronic Heart Failure

Official Title

Prospective, Randomized Comparison of Therapy With Verapamil or Carvedilol on Long-Term Outcomes of Patients With Chronic Heart Failure Secondary to Non-Ischemic Cardiomyopathy

Brief Summary

      The aim of this study is to compare the effect of treatment with verapamil or carvedilol on
      long-term outcomes in stable, chronic heart failure secondary to non-ischemic cardiomyopathy.
    

Detailed Description

      Heart failure, irrespective of its etiology may be viewed as a progressive disorder initiated
      by a different events and sustained by a multifaceted pathophysiological mechanisms.
      Regardless of the nature of the initiating events and optimized therapy used, loss of
      functioning cardiac myocytes developed and the disease progressed. One potential explanation
      for such progression is that not all pathological mechanisms underlying the disease are
      antagonized enough by currently used therapeutic strategy. Accordingly, impaired myocardial
      perfusion secondary to microvascular dysfunction has been postulated to play a major role in
      the progression of heart failure despite standard therapy for heart failure. It has been
      hypothesized that diffuse subendocardial ischemia due to altered coronary physiology may
      contribute to the global cardiac dysfunction seen in heart failure patients. Accordingly,
      coronary endothelial dysfunction at the microvascular and epicardial level in patients with
      acute-onset idiopathic dilated cardiomyopathy and chronic congestive heart failure has been
      reported. Thus, taking all mentioned above into account, the improvement in endothelial
      function and diminishing of subendocardial ischemia with calcium antagonists may be promising
      in terms of using these drugs for therapy of patients with stable chronic heart failure. The
      previous randomized study (5) and our long-term pilot study support this point of view.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Sserum level of NT-proBNP,LVEF, LV diameters, exercise capacity (NYHA, V02,6 min walking test, changes in quality of life (MLHFQ).

Secondary Outcome

 Combined: mortality, heart transplantation, and readmission to hospital due to heart failure progression

Condition

Dilated Cardiomyopathy

Intervention

Verapamil


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

January 2006

Completion Date

May 2008


Eligibility Criteria

        Inclusion Criteria:

          -  Chronic heart failure (NYHA II and III; LV ejection fraction, ≤ 35%) secondary to
             non-ischemic cardiomyopathy

          -  Stable condition at least 6 months before enrollment on conventional therapy
             (beta-blockers, ACE inhibitors and diuretics).

        Exclusion Criteria:

          -  Improvement in clinical status on conventional therapy in out-patients period preceded
             hospitalization,

          -  Any changes narrowing epicardial coronary arteries in coronary angiography,

          -  Insulin dependent diabetes,

          -  Valvular heart disease (except the relative mitral regurgitation),

          -  Endocrine disease

          -  Significant renal and liver disease

          -  Alcohol abuse

          -  Lack of written informed consent
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Jan Wodniecki, Prof., +48 32 2716471, [email protected]

Location Countries

Poland

Location Countries

Poland

Administrative Informations


NCT ID

NCT00374465

Organization ID

CavsBe.06



Study Sponsor

Medical University of Silesia


Study Sponsor

Jan Wodniecki, Prof., Study Chair, Medical University of Silesia


Verification Date

September 2006