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Therapy With Verapamil or Carvedilol in Chronic Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Medical University of Silesia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Silesia
ClinicalTrials.gov Identifier:
NCT00374465
First received: September 8, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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 Intervention Phase
Dilated Cardiomyopathy
 Drug: Verapamil
Drug: Carvedilol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Silesia:

Primary Outcome Measures:
  • Sserum level of NT-proBNP,LVEF, LV diameters, exercise capacity (NYHA, V02,6 min walking test, changes in quality of life (MLHFQ).
  • 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:
  • Combined: mortality, heart transplantation, and readmission to hospital due to heart failure progression

Estimated Enrollment: 100
Study Start Date: January 2006
Estimated Study Completion Date: May 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374465

Contacts
Contact: Jan Wodniecki, MD, PhD +48 32 2716471 ext 228 wojnicz@dom.zabrze.pl
Contact: Ewa Nowalany Kozielska, MD, PhD +48 32 2525767 ewakozielska@wp.pl

Locations
Poland
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
Investigators
Study Chair: Jan Wodniecki, Prof. Medical University of Silesia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00374465     History of Changes
Other Study ID Numbers: CavsBe.06
Study First Received: September 8, 2006
Last Updated: September 8, 2006
Health Authority: Poland: Institutional Review Board

Keywords provided by Medical University of Silesia:
Dilated Cardiomyopathy
Heart Failure

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Heart Failure
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Carvedilol
Verapamil
Diltiazem
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on May 16, 2013