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Effects of Carvedilol on Health Outcomes in Heart Failure

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00381030
Enrollment
100
Registered
2006-09-27
Start date
2002-10-31
Completion date
2005-03-31
Last updated
2006-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Congestive

Keywords

beta-Adrenergic Blockers, Disease Management

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.

Interventions

DRUGcarvedilol plus nurse management

Sponsors

Denver Health and Hospital Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026