IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting - Full Text View

Sponsors and Collaborators:	Medtronic Cardiac Rhythm Disease Management Medtronic
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00303979

Purpose

The purpose of this study is to characterize current management of patients with either heart failure or prior myocardial infarction and left ventricular dysfunction and to assess the effect of education, specific clinical guidelines, reminder systems, comprehensive disease state management tools, benchmarked quality reports, and academic detailing on the use of evidence-based heart failure therapies in cardiology practices. This study is a quality improvement initiative that is being conducted through review of patient records.

Condition	Intervention
Heart Failure, Congestive Myocardial Infarction Ventricular Dysfunction, Left	Behavioral: Evidence based guidelines and tools

MedlinePlus related topics: Heart Attack Heart Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:

To observe over the aggregate IMPROVE-HF practice sites a relative 20% or greater improvement in at least 2 of the 7 performance measures at 24 months compared with baseline. [ Time Frame: Study Completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other measures to determine variations in how practices treat heart failure patients and variations in different patients. [ Time Frame: Study Completion ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40000
Study Start Date:	May 2005
Estimated Study Completion Date:	July 2009

Groups/Cohorts	Assigned Interventions
1	Behavioral: Evidence based guidelines and tools Education, guidelines, tools
2	Behavioral: Evidence based guidelines and tools Education, guidelines, tools
3	Behavioral: Evidence based guidelines and tools Education, guidelines, tools

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Heart failure patients in outpatient cardiology practices

Criteria

Inclusion Criteria:

18 years of age or older
Primary or secondary diagnosis of heart failure or prior myocardial infarction (heart attack)
Moderate-to-severe left ventricular dysfunction (LVD) as demonstrated by an ejection fraction < or = 35% and/or a qualitative assessment of LVD of moderate-to-severe or severe LVD
Patient has been seen at the clinic at least twice in the past 2 years
Patient received care from the physician participating in the study

Exclusion Criteria:

Patient has died
Patient is not expected to survive for 12 months due to medical conditions other than heart failure
Patient has undergone heart transplant surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303979

Show 139 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Medtronic

Investigators

Study Chair:	Gregg Fonarow, MD	University of California at Los Angeles
Study Chair:	Clyde Yancy, MD	UT Southwestern Medical Center at Dallas

More Information

Responsible Party:	Medtronic CRDM ( CRDM Core Clinical )
Study ID Numbers:	258
Study First Received:	March 15, 2006
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00303979
Health Authority:	United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Systolic Heart Failure
Quality of Care
Outcomes
Evidence-based Guidelines
Recommended Therapies

Study placed in the following topic categories:

Ventricular Dysfunction
Necrosis
Heart Failure
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ventricular Dysfunction, Left
Ischemia
Infarction
Myocardial Infarction
Heart Failure, Systolic

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009