Carvedilol Versus Verapamil in Chronic Heart Failure Secondary to Non-Ischemic Cardiomyopathy
Information source: Medical University of Silesia
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Systolic Heart Failure; Myocardial Disease; Cardiomyopathy
Intervention: Verapamil (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Medical University of Silesia Official(s) and/or principal investigator(s):
Romuald Wojnicz, MD, PhD, Principal Investigator, Affiliation: Medical University of Silesia
Summary
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.
Clinical Details
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 design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: NT-proBNP; LVEF(radionuclide ventriculography; LVFS; LVDD/LVSD, NYHA class, V02, 6 min walking test, MLWHFQ.
Secondary outcome: Death; Heart transplantation; Readmission to hospital.
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.
1. 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.
2. 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.
3. 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.
4. 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.
5. 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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Silesian Center for Heart Disease, IIIrd Department of Cardiology, Silesian Medical University, Zabrze 41-800, Poland; Recruiting
Romuald Wojnicz, MD, PhD, Phone: +48-32-2732272, Email: wojnicz@dom.zabrze.pl
Romuald Wojnicz, MD, PhD, Principal Investigator
Ewa Nowalany-Kozielska, MD, PhD, Sub-Investigator
Jolanta Nowak, MD, Sub-Investigator
Bożena Szyguła-Jurkiewicz, MD, Sub-Investigator
Krzysztof Wilczek, MD, Sub-Investigator
Additional Information
Starting date: January 2006
Ending date: December 2007
Last updated: October 17, 2006
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