Therapy With Verapamil or Carvedilol in Chronic Heart Failure

NCT00374465 | Unknown Phase 4

• 1 other identifier: CavsBe.06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dilated Cardiomyopathy

Keywords

Dilated Cardiomyopathy; Heart Failure

Outcome Measures

Primary Outcomes (2)

• Sserum level of NT-proBNP,LVEF, LV diameters, exercise capacity (NYHA, V02,6 min walking test, changes in quality of life (MLHFQ).

• 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 Outcomes (1)

• Combined: mortality, heart transplantation, and readmission to hospital due to heart failure progression

Interventions

Verapamil DRUG

Carvedilol DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

Silesian Centre for Heart Disease, 3rd Department of Cardiology

Zabrze, Szpitalna 2 Saint, 41800, Poland

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Heart Failure

Interventions

Verapamil; Carvedilol

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals; Propanolamines; Amino Alcohols; Alcohols; Propanols; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Jan Wodniecki, Prof.

  Medical University of Silesia

  STUDY CHAIR

Central Study Contacts

Jan Wodniecki, MD, PhD

CONTACT

+48 32 2716471; wojnicz@dom.zabrze.pl

Ewa Nowalany Kozielska, MD, PhD

CONTACT

+48 32 2525767; ewakozielska@wp.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2006
• First Posted: September 11, 2006
• Study Start: January 1, 2006
• Study Completion: May 1, 2008
• Last Updated: September 11, 2006

Record last verified: 2006-09

Locations

PL (1)