Effects of Carvedilol on Health Outcomes in Heart Failure

Study Overview
=================
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.

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

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Drug: carvedilol plus nurse management


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carvedilol plus nurse management|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome: heart failure hospitalizations, time to death or hospitalization |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular ejection fraction and volume in systole and diastole |  |  | 
| beta-blocker utilization/adherence |  |  | 
| new york heart association functional class |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
beta-Adrenergic Blockers, Disease Management