Effects of Carvedilol on Health Outcomes in Heart Failure

Phase 4

Completed

• Conditions: Heart Failure, Congestive

• Registration Number: NCT00381030
• Lead Sponsor: Denver Health and Hospital Authority

Brief Summary

The purpose of our study was to determine if a strategy of starting a heart medication (Beta-blocker) before patients leave the hospital and then being seen by a nurse manager would reduce subsequent hospitalizations compared to usual care.

Hypothesis: A nurse-directed heart failure management program with inpatient initiation of beta blockers will improve health outcomes in a vulnerable, predominantly Hispanic and African American population.

Detailed Description

Heart failure is a leading cause of death and hospitalization in the US. Designing practical approaches to improving heart failure care is therefore a national health priority. One retrospective study suggested that patients taking beta-blockers while hospitalized for heart failure had a lower risk of rehospitalization at 6-months. One prospective study suggested that starting beta blockers among hospitalized heart failure patients is safe and improves compliance. However, improved outcomes of this approach have not been prospectively demonstrated.

Comparison: Inpatient initiation of the beta-blocker carvedilol coupled with outpatient follow-up with a nurse manager was compared to usual care by internists and cardiologists.

Study Timeline

• Study Start: 2002-10
• Study Completion: 2005-03
• Status Verified: 2006-09
• Study First Submitted: 2006-09-25
• Study First Submitted QC: 2006-09-25
• Last Update Submitted: 2006-09-25
• Study First Posted: 2006-09-27
• Last Update Posted: 2006-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• primary hospitalization with heart failure and LVEF < 40%
• patient informed consent has been obtained
• absence of pulmonary congestion
• age > 18 years

Exclusion Criteria

• End-stage renal or hepatic disease
• Acute myocardial infarction as primary diagnosis during index hospitalization
• Life-expectancy < 6-months
• Contraindication to beta blocker use
• Current beta-blocker therapy
• Planned bypass or valve surgery during index hospitalization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary outcome: heart failure hospitalizations, time to death or hospitalization

Secondary Outcome Measures

Name	Time	Method
left ventricular ejection fraction and volume in systole and diastole
beta-blocker utilization/adherence
new york heart association functional class

Trial Locations

Locations (1)

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States