Therapy With Verapamil or Carvedilol in Chronic Heart Failure - Full Text View

Sponsor:	Medical University of Silesia
Information provided by:	Medical University of Silesia
ClinicalTrials.gov Identifier:	NCT00374465

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 IV

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:

MedlinePlus related topics: Cardiomyopathy Heart Failure

Drug Information available for: Verapamil Diltiazem hydrochloride Dexverapamil Diltiazem Carvedilol Diltiazem malate Verapamil hydrochloride

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 February 09, 2012