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Therapy With Verapamil or Carvedilol in Chronic Heart Failure

M

Medical University of Silesia

Status and phase

Unknown
Phase 4

Conditions

Dilated Cardiomyopathy

Treatments

Drug: Carvedilol
Drug: Verapamil

Study type

Interventional

Funder types

Other

Identifiers

NCT00374465
CavsBe.06

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Central trial contact

Ewa Nowalany Kozielska, MD, PhD; Jan Wodniecki, MD, PhD

Data sourced from clinicaltrials.gov

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