Effects of Carvedilol on Health Outcomes in Heart Failure

Heart Failure, Congestive Clinical Trial

Official title:

Effects of Inpatient Initiation of Carvedilol and Nurse Management on Health Outcomes in Vulnerable Heart Failure Patients (ECHO Study): a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381030
• Other study ID #: SKF105517/379
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2006
• Last updated: September 25, 2006
• Start date: October 2002
• Est. completion date: March 2005

Study information

• Verified date: September 2006
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• carvedilol plus nurse management

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome: heart failure hospitalizations, time to death or hospitalization
Secondary	left ventricular ejection fraction and volume in systole and diastole
Secondary	beta-blocker utilization/adherence
Secondary	new york heart association functional class