Clinical trial NCT00381030: Effects of Carvedilol on Health Outcomes in Heart Failure
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure, Congestive
Keywords: beta-Adrenergic Blockers
Disease Management
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2006-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Primary outcome: heart failure hospitalizations, time to death or hospitalization
Secondary outcomes:
measure: left ventricular ejection fraction and volume in systole and diastole
measure: beta-blocker utilization/adherence
measure: new york heart association functional class
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health Medical Center
name: Mori J Krantz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krantz MJ, Havranek EP, Haynes DK, Smith I, Bucher-Bartelson B, Long CS. Inpatient initiation of beta-blockade plus nurse management in vulnerable heart failure patients: a randomized study. J Card Fail. 2008 May;14(4):303-9. doi: 10.1016/j.cardfail.2007.12.008.