Organized Program To Initiate Lifesaving Treatment In Hospitalized Patients With Heart Failure (OPTIMIZE-HF)
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: Beta-blockers including Carvedilol (Drug); ACE inhibitors (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
This program is designed to improve medical care and education of hospitalized patients with
heart failure and accelerate the initiation of evidence-based heart failure guideline
recommended therapies by administering them before hospital discharge. A registry component
focusing on admission to discharge and 60- to 90-day follow-up is designed to evaluate the
demographic, pathophysiologic, clinical, treatment, and outcome characteristics of patients
hospitalized with heart failure.
Clinical Details
Official title: Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure (OPTIMIZE-HF): An Internet-Based Registry and Process of Care Improvement Program for Heart Failure Patients
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Evaluate the number and percentage of eligible patients who are discharged on optimal therapy.
Evaluate all HF indicators recommended by JCAHO and CMS.
Secondary outcome: Mortality
Recurrent hospitalization
Number of patients receiving beta-blockers therapy within 60 to 90 days of initiation and mean beta-blocker dose 60-90 days following discharge.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Hospitalized for episode of worsening heart failure as primary cause of admission or
significant heart failure symptoms that develop during the hospitalization when the
initial reason for admission was not heart failure.
- Systolic dysfunction (LVEF < 40%) or heart failure symptoms in the setting of
preserved systolic function (diastolic dysfunction).
Exclusion criteria:
- This study has no exclusion criteria.
Locations and Contacts
Additional Information
Starting date: December 2002
Last updated: June 23, 2006
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