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

Sponsor:	Medical University of Silesia
Information provided by:	Medical University of Silesia
ClinicalTrials.gov Identifier:	NCT00348530

Purpose

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	Intervention	Phase
Systolic Heart Failure Myocardial Disease Cardiomyopathy	Drug: Verapamil	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/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:

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

Secondary Outcome Measures:

Death; Heart transplantation; Readmission to hospital.

Estimated Enrollment:	120
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2007

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.

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.
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.
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.
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.
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.

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,
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348530

Locations

Poland
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 wojnicz@dom.zabrze.pl
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

Investigators

Principal Investigator:

Romuald Wojnicz, MD, PhD

Medical University of Silesia

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00348530 History of Changes
Other Study ID Numbers:	CavsBe.2006
Study First Received:	July 3, 2006
Last Updated:	October 17, 2006
Health Authority:	Poland: Ministry of Science and Higher Education

Keywords provided by Medical University of Silesia:

Systolic heart failure; Therapy; Cardiomyopathy

Additional relevant MeSH terms:

Heart Failure
Cardiomyopathies
Heart Failure, Systolic
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 12, 2012