Back to resultsEffects of Carvedilol on Health Outcomes in Heart Failure
Primary Purpose
Heart Failure, Congestive
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
carvedilol plus nurse management
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring beta-Adrenergic Blockers, Disease Management
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
Sites / Locations
- Denver Health Medical Center
Outcomes
Primary Outcome Measures
Primary outcome: heart failure hospitalizations, time to death or hospitalization
Secondary Outcome Measures
left ventricular ejection fraction and volume in systole and diastole
beta-blocker utilization/adherence
new york heart association functional class
Full Information
NCT ID
NCT00381030
First Posted
September 25, 2006
Last Updated
September 25, 2006
Sponsor
Denver Health and Hospital Authority
1. Study Identification
Unique Protocol Identification Number
NCT00381030
Brief Title
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
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Denver Health and Hospital Authority
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
beta-Adrenergic Blockers, Disease Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
carvedilol plus nurse management
Primary Outcome Measure Information:
Title
Primary outcome: heart failure hospitalizations, time to death or hospitalization
Secondary Outcome Measure Information:
Title
left ventricular ejection fraction and volume in systole and diastole
Title
beta-blocker utilization/adherence
Title
new york heart association functional class
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mori J Krantz, MD
Organizational Affiliation
Denver Health Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18474343
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.
Results Reference
derived
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Effects of Carvedilol on Health Outcomes in Heart Failure
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