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Therapy With Verapamil or Carvedilol in Chronic Heart Failure

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: NCT00374465
Recruitment Status : Unknown
Verified September 2006 by Medical University of Silesia.
Recruitment status was:  Recruiting
First Posted : September 11, 2006
Last Update Posted : September 11, 2006
Information provided by:
Medical University of Silesia

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.

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Drug: Verapamil Drug: Carvedilol 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. 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 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 : May 2008

Primary Outcome Measures :
  1. Sserum level of NT-proBNP,LVEF, LV diameters, exercise capacity (NYHA, V02,6 min walking test, changes in quality of life (MLHFQ).
  2. In addition to secondary endpoints efficacy, patients will be classified as improved if they meet an increase of > 10 percentage points in the absolute EF and decrease in NT-proBNP levels at least 50% as compared with baseline study.

Secondary Outcome Measures :
  1. Combined: mortality, heart transplantation, and readmission to hospital due to heart failure progression

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
  • Significant renal and liver disease
  • Alcohol abuse
  • Lack of written informed consent

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): NCT00374465

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Contact: Jan Wodniecki, MD, PhD +48 32 2716471 ext 228
Contact: Ewa Nowalany Kozielska, MD, PhD +48 32 2525767

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Silesian Centre for Heart Disease, 3rd Department of Cardiology Recruiting
Zabrze, Szpitalna 2 st., Poland, 41800
Principal Investigator: Romuald Wojnicz, MD, PhD         
Sub-Investigator: Ewa N Kozielska, MD, PhD         
Sub-Investigator: Jolanta Nowak, MD         
Sub-Investigator: Krzysztof Wilczek, MD         
Sub-Investigator: Celina Wojciechowska, MD         
Sub-Investigator: Bozena Szygula, MD         
Sponsors and Collaborators
Medical University of Silesia
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Study Chair: Jan Wodniecki, Prof. Medical University of Silesia
Layout table for additonal information Identifier: NCT00374465    
Other Study ID Numbers: CavsBe.06
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: September 2006
Keywords provided by Medical University of Silesia:
Dilated Cardiomyopathy
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathy, Dilated
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