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Effects of Carvedilol on Health Outcomes in Heart Failure

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ClinicalTrials.gov Identifier: NCT00381030
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : September 27, 2006
Sponsor:
Information provided by:
Denver Health and Hospital Authority

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.


Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Drug: carvedilol plus nurse management Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2002
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Carvedilol




Primary Outcome Measures :
  1. Primary outcome: heart failure hospitalizations, time to death or hospitalization

Secondary Outcome Measures :
  1. left ventricular ejection fraction and volume in systole and diastole
  2. beta-blocker utilization/adherence
  3. new york heart association functional class


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381030


Locations
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United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
Investigators
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Principal Investigator: Mori J Krantz, MD Denver Health Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00381030    
Other Study ID Numbers: SKF105517/379
First Posted: September 27, 2006    Key Record Dates
Last Update Posted: September 27, 2006
Last Verified: September 2006
Keywords provided by Denver Health and Hospital Authority:
beta-Adrenergic Blockers
Disease Management
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists