NCT00381030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
Last Updated

September 27, 2006

Status Verified

September 1, 2006

First QC Date

September 25, 2006

Last Update Submit

September 25, 2006

Conditions

Heart Failure, Congestive

Keywords

beta-Adrenergic BlockersDisease Management

Outcome Measures

Primary Outcomes (1)

  • Primary outcome: heart failure hospitalizations, time to death or hospitalization

Secondary Outcomes (3)

  • left ventricular ejection fraction and volume in systole and diastole

  • beta-blocker utilization/adherence

  • new york heart association functional class

Interventions

carvedilol plus nurse managementDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • primary hospitalization with heart failure and LVEF \< 40%
  • patient informed consent has been obtained
  • absence of pulmonary congestion
  • age \> 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Related Publications (1)

  • 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.

    PMID: 18474343DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-Ring

Study Officials

  • Mori J Krantz, MD

    Denver Health Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 27, 2006

Study Start

October 1, 2002

Study Completion

March 1, 2005

Last Updated

September 27, 2006

Record last verified: 2006-09

Locations

US(1)