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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00374465
Other study ID # CavsBe.06
Secondary ID
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
Est. primary completion date
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


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
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