Therapy With Verapamil or Carvedilol in Chronic Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dilated Cardiomyopathy

Keywords

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Dilated Cardiomyopathy Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Verapamil

Intervention Type DRUG

Carvedilol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jan Wodniecki, Prof.

Role: STUDY_CHAIR

Medical University of Silesia

Locations

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Silesian Centre for Heart Disease, 3rd Department of Cardiology

Zabrze, Szpitalna 2 Saint, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Jan Wodniecki, MD, PhD

Role: CONTACT

Phone: +48 32 2716471

Email: [email protected]

Ewa Nowalany Kozielska, MD, PhD