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Completed

NCT Number: NCT00381030

Effects of Carvedilol on Health Outcomes in Heart Failure

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.

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Key information

Conditions

Heart Failure, Congestive Cardiovascular Diseases Heart Diseases Heart Failure

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Denver Health Medical Center

Denver, Colorado, 80204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carvedilol plus nurse management

Drug

Primary outcomes

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

Secondary outcomes

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

  2. beta-blocker utilization/adherence

  3. new york heart association functional class

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2005
First posted
Sep 27, 2006
Registry last updated
Sep 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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