Heart Failure, Congestive Clinical Trial
Official title:
Effects of Inpatient Initiation of Carvedilol and Nurse Management on Health Outcomes in Vulnerable Heart Failure Patients (ECHO Study): a Randomized Trial
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Denver Health Medical Center | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
Denver Health and Hospital Authority |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary outcome: heart failure hospitalizations, time to death or hospitalization | |||
Secondary | left ventricular ejection fraction and volume in systole and diastole | |||
Secondary | beta-blocker utilization/adherence | |||
Secondary | new york heart association functional class |
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