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Effects of Carvedilol on Health Outcomes in Heart Failure

Sponsor
Denver Health and Hospital Authority (Other)
Overall Status
Completed
CT.gov ID
NCT00381030
Collaborator
(none)
100
Enrollment
1
Location
29
Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: carvedilol plus nurse management
 Phase 4

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Oct 1, 2002
Study Completion Date :
Mar 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Primary outcome: heart failure hospitalizations, time to death or hospitalization []

Secondary Outcome Measures

  1. left ventricular ejection fraction and volume in systole and diastole []

  2. beta-blocker utilization/adherence []

  3. new york heart association functional class []

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Denver Health Medical Center Denver Colorado United States 80204

Sponsors and Collaborators

  • Denver Health and Hospital Authority

Investigators

  • Principal Investigator: Mori J Krantz, MD, Denver Health Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00381030
Other Study ID Numbers:
  • SKF105517/379
First Posted:
Sep 27, 2006
Last Update Posted:
Sep 27, 2006
Last Verified:
Sep 1, 2006
Keywords provided by , ,
beta-Adrenergic Blockers
Disease Management
Additional relevant MeSH terms:
Heart Failure
Carvedilol

Study Results

No Results Posted as of Sep 27, 2006