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Carvedilol Versus Verapamil in Chronic Heart Failure Secondary to Non-Ischemic Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00348530
Recruitment Status : Unknown
Verified January 2006 by Medical University of Silesia.
Recruitment status was:  Recruiting
First Posted : July 4, 2006
Last Update Posted : October 18, 2006
Information provided by:
Medical University of Silesia

Brief Summary:
Accumulated clinical and experimental data suggest that dysfunctional coronary microcirculation plays a pivotal role in the progression of heart failure despite an optimal therapy used. Therefore, we hypothesize that improvement in microvascular function by calcium antagonist, verapamil may result in additional clinical benefit. Thus, 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.

Condition or disease Intervention/treatment Phase
Systolic Heart Failure Myocardial Disease Cardiomyopathy Drug: Verapamil Phase 4

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 (1). 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 (2). 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 (3,4) 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.

  1. Neglia D, Michelassi C, Trivieri MG, et al. Prognostic role of myocardial blood flow impairment in idiopathic left ventricular dysfunction. Circulation 2002;105:186-193.
  2. Unverferth DV, Magorien RD, Lewis RP, et al. The role of subendocardial ischemia in perpetuating myocardial failure in patients with nonischemic congestive cardiomyopathy. Am Heart J 1983;105:176-179.
  3. Mathier MA, Rose GA, Fifer MA, et al. Coronary endothelial dysfunction in patients with acute-onset idiopathic dilated cardiomyopathy. J Am Coll Cardiol 1998;32:216-224.
  4. Chong AY, Blann AD, Patel J, et al. Endothelial dysfunction and damage in congestive heart failure. Relation of flow-mediated dilation to circulating endothelial cells, plasma indexes of endothelial damage, and brain natriuretic peptide. Circulation 2004;110:1794-1798.
  5. Figulla HR, Gietzen F, Zeymer U, et al. Diltiazem improves cardiac function and exercise capacity in patients with idiopathic dilated cardiomyopathy. Results of diltiazem in dilated cardiomyopathy trial. Circulation 1996;94:346-352.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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
Study Start Date : January 2006
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Carvedilol

Primary Outcome Measures :
  1. NT-proBNP; LVEF(radionuclide ventriculography; LVFS; LVDD/LVSD, NYHA class, V02, 6 min walking test, MLWHFQ.

Secondary Outcome Measures :
  1. Death; Heart transplantation; Readmission to hospital.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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,
  • lack of written informed consent,
  • significant renal and liver diseases,
  • drug or alcohol abuse,
  • therapy with steroids or calcium blockers within 3 months before screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00348530

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Silesian Center for Heart Disease, IIIrd Department of Cardiology, Silesian Medical University Recruiting
Zabrze, Poland, 41-800
Contact: Romuald Wojnicz, MD, PhD    +48-32-2732272   
Principal Investigator: Romuald Wojnicz, MD, PhD         
Sub-Investigator: Ewa Nowalany-Kozielska, MD, PhD         
Sub-Investigator: Jolanta Nowak, MD         
Sub-Investigator: Bożena Szyguła-Jurkiewicz, MD         
Sub-Investigator: Krzysztof Wilczek, MD         
Sponsors and Collaborators
Medical University of Silesia
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Principal Investigator: Romuald Wojnicz, MD, PhD Medical University of Silesia

Layout table for additonal information Identifier: NCT00348530     History of Changes
Other Study ID Numbers: CavsBe.2006
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: October 18, 2006
Last Verified: January 2006

Keywords provided by Medical University of Silesia:
Systolic heart failure; Therapy; Cardiomyopathy

Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Anti-Arrhythmia Agents