Organized Program To Initiate Lifesaving Treatment In Hospitalized Patients With Heart Failure (OPTIMIZE-HF)

Heart Failure, Congestive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344513
• Other study ID #: 105517/358
• Status: Completed
• Phase: Phase 4
• Start date: December 16, 2002
• Est. completion date: June 30, 2005

Study information

• Verified date: November 2020
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50000
• Est. completion date: June 30, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• Beta-blockers including Carvedilol

• ACE inhibitors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the number and percentage of eligible patients who are discharged on optimal therapy. Evaluate all HF indicators recommended by JCAHO and CMS.
Secondary	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.