Effects of Carvedilol on Health Outcomes in Heart Failure - Full Text View

Sponsor:	Denver Health and Hospital Authority
Information provided by:	Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:	NCT00381030

Purpose

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.

Condition	Intervention	Phase
Heart Failure, Congestive	Drug: carvedilol plus nurse management	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Effects of Inpatient Initiation of Carvedilol and Nurse Management on Health Outcomes in Vulnerable Heart Failure Patients (ECHO Study): a Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Carvedilol

U.S. FDA Resources

Further study details as provided by Denver Health and Hospital Authority:

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

Estimated Enrollment:	100
Study Start Date:	October 2002
Estimated Study Completion Date:	March 2005

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381030

Locations

United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204

Sponsors and Collaborators

Denver Health and Hospital Authority

Investigators

Principal Investigator:

Mori J Krantz, MD

Denver Health Medical Center

More Information

No publications provided by Denver Health and Hospital Authority

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	SKF105517/379
Study First Received:	September 25, 2006
Last Updated:	September 25, 2006
ClinicalTrials.gov Identifier:	NCT00381030 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Denver Health and Hospital Authority:

beta-Adrenergic Blockers
Disease Management

Additional relevant MeSH terms:

Vasodilator Agents
Heart Failure
Neurotransmitter Agents
Heart Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Carvedilol

ClinicalTrials.gov processed this record on February 08, 2010