Effects of Carvedilol on Health Outcomes in Heart Failure

Condition(s) targeted: Heart Failure, Congestive

Intervention: carvedilol plus nurse management (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Denver Health and Hospital Authority

Official(s) and/or principal investigator(s):
Mori J Krantz, MD, Principal Investigator, Affiliation: Denver Health Medical Center

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.

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

Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

Secondary outcome:

left ventricular ejection fraction and volume in systole and diastole

beta-blocker utilization/adherence

new york heart association functional class

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Denver Health Medical Center, Denver, Colorado 80204, United States

Starting date: October 2002
Ending date: March 2005
Last updated: September 25, 2006