Therapy With Verapamil or Carvedilol in Chronic Heart Failure

Dilated Cardiomyopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00374465
• Other study ID #: CavsBe.06
• Status: Recruiting
• Phase: Phase 4
• First received: September 8, 2006
• Last updated: September 8, 2006
• Start date: January 2006
• Est. completion date: May 2008

Study information

• Verified date: September 2006
• Source: Medical University of Silesia
• Contact: Jan Wodniecki, MD, PhD
• Phone: +48 32 2716471
• Email: wojnicz[@]dom.zabrze.pl
• Is FDA regulated: No
• Health authority: Poland: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Heart Failure

Intervention

Drug:
• Verapamil

• Carvedilol

Locations

Country	Name	City	State
Poland	Silesian Centre for Heart Disease, 3rd Department of Cardiology	Zabrze, Szpitalna 2 st.

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sserum level of NT-proBNP,LVEF, LV diameters, exercise capacity (NYHA, V02,6 min walking test, changes in quality of life (MLHFQ).
Primary	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	Combined: mortality, heart transplantation, and readmission to hospital due to heart failure progression