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Effects of Carvedilol on Health Outcomes in Heart Failure

D

Denver Health and Hospital Authority

Status and phase

Completed
Phase 4

Conditions

Heart Failure, Congestive

Treatments

Drug: carvedilol plus nurse management

Study type

Interventional

Funder types

Other

Identifiers

NCT00381030
SKF105517/379

Details and patient eligibility

About

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.

Full 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.

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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