MedDataX Logo

Effects of Carvedilol on Health Outcomes in Heart Failure

NCT ID: NCT00381030

Last Updated: 2006-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2005-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure, Congestive

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

beta-Adrenergic Blockers Disease Management

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

carvedilol plus nurse management

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Denver Health and Hospital Authority

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mori J Krantz, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Health Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Denver Health Medical Center

Denver, Colorado, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 18474343 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SKF105517/379

Identifier Type: -

Identifier Source: org_study_id