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| Sponsored by: |
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: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | December 2007 |
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.
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Romuald Wojnicz, MD, PhD | Medical University of Silesia |
More Information
| Study ID Numbers: | CavsBe.2006 |
| Study First Received: | July 3, 2006 |
| Last Updated: | October 17, 2006 |
| ClinicalTrials.gov Identifier: | NCT00348530 History of Changes |
| Health Authority: | Poland: Ministry of Science and Higher Education |
|
Systolic heart failure; Therapy; Cardiomyopathy |
|
Heart Failure Vasodilator Agents Heart Diseases Calcium Channel Blockers Cardiovascular Agents Antihypertensive Agents Cardiomyopathies |
Heart Failure, Systolic Calcium, Dietary Verapamil Diltiazem Neoplasm Metastasis Anti-Arrhythmia Agents Carvedilol |
|
Vasodilator Agents Heart Failure Heart Diseases Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Cardiovascular Agents Antihypertensive Agents Cardiomyopathies |
Pharmacologic Actions Heart Failure, Systolic Membrane Transport Modulators Verapamil Therapeutic Uses Diltiazem Cardiovascular Diseases Anti-Arrhythmia Agents |