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

NCT ID: NCT00303979

Last Updated: 2019-01-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34810 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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IMPROVE HF, the largest US outpatient HF patient registry, has substantially contributed to our knowledge of how systolic HF and post MI left ventricular systolic dysfunction (LVSD) patients are treated in the outpatient setting.

The findings of IMPROVE HF clearly support this guideline and may help to establish a model framework for future performance improvement programs for outpatient cardiology practices.

Conditions

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Heart Failure, Congestive Myocardial Infarction Ventricular Dysfunction, Left

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A (longitudinal)

Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months

No interventions assigned to this group

Cohort B (6 Month)

6 Month Cohort: Approximately 10,000 patients reviewed at single time point

No interventions assigned to this group

Cohort C (18 Month)

18 Month Cohort: Approximately 10,000 patients reviewed at single time point

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregg Fonarow, MD

Role: STUDY_CHAIR

University of California at Los Angeles

Clyde Yancy, MD

Role: STUDY_CHAIR

UT Southwestern Medical Center at Dallas

Locations

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Cardiovascular Associates of Montclair

Birmingham, Alabama, United States

Site Status

Cardiology Associates

Mobile, Alabama, United States

Site Status

Cardiovascular Associates of Mesa

Mesa, Arizona, United States

Site Status

Heart Care, PC

Scottsdale, Arizona, United States

Site Status

Southern Arizona VA Health Care System

Tucson, Arizona, United States

Site Status

Central Arkansas Cardiovascular Institute

Hot Springs, Arkansas, United States

Site Status

Arkansas Cardiology Clinic

Little Rock, Arkansas, United States

Site Status

St. Jude Heritage Medical Group

Fullerton, California, United States

Site Status

Scripps Clinic Green Hospital

La Jolla, California, United States

Site Status

Veterans Administration Hospital

Los Angeles, California, United States

Site Status

University Cardiovascular Medical Group

Los Angeles, California, United States

Site Status

Cardio-Pulmonary Associates

Monterey, California, United States

Site Status

Temecula Valley Cardiology

Murrieta, California, United States

Site Status

California Pacific Cardiovascular Medical

San Francisco, California, United States

Site Status

East Bay Cardiology

San Pablo, California, United States

Site Status

Cardiology Consultants Medical Group

Tarzana, California, United States

Site Status

Medical Center of the Rockies

Fort Collins, Colorado, United States

Site Status

Connecticut Heart & Vascular Center

Bridgeport, Connecticut, United States

Site Status

Cardiology Consultants, PA

Newark, Delaware, United States

Site Status

Heart and Vascular Center of Bradenton

Bradenton, Florida, United States

Site Status

Clearwater Cardiovascular & Intervention

Clearwater, Florida, United States

Site Status

Mahesh Amin, MD PA

Clearwater, Florida, United States

Site Status

Pasco Cardiology

Hudson, Florida, United States

Site Status

Cardiovascular Associates

Kissimmee, Florida, United States

Site Status

Clark and Daughtrey Medical Group

Lakeland, Florida, United States

Site Status

OMNI

Melbourne, Florida, United States

Site Status

Miami Cardiology Group

Miami, Florida, United States

Site Status

Florida Heart Group

Orlando, Florida, United States

Site Status

Cardiology Associates

Port Charlotte, Florida, United States

Site Status

Cardiovascular Consultants,

Tamarac, Florida, United States

Site Status

Indian River Cardiovascular Associate

Vero Beach, Florida, United States

Site Status

Florida Medical Clinic

Zephyrhills, Florida, United States

Site Status

Cardiology of Atlanta

Atlanta, Georgia, United States

Site Status

Northside Cardiology

Atlanta, Georgia, United States

Site Status

Northeast Georgia Heart Center

Gainesville, Georgia, United States

Site Status

Southcoast Cardiology

Savannah, Georgia, United States

Site Status

Pacific Cardiology

Honolulu, Hawaii, United States

Site Status

St. Luke's Idaho Cardiology Associates

Boise, Idaho, United States

Site Status

Heart Care Center of Illinois

Blue Island, Illinois, United States

Site Status

MidAmerica Cardiovascular Consultants

Frankfort, Illinois, United States

Site Status

Cardiovascular Associates of Glenbrook and Evanston, LLC

Glenview, Illinois, United States

Site Status

St. Vincent's Hospital

Indianapolis, Indiana, United States

Site Status

Methodist Hospital

Indianapolis, Indiana, United States

Site Status

St. Vincent's Hospital Indianapolis

Indianapolis, Indiana, United States

Site Status

St. Vincent's Hospital,

Indianapolis, Indiana, United States

Site Status

Iowa Heart Center PC,

West Des Moines, Iowa, United States

Site Status

Mid America Cardiology

Kansas City, Kansas, United States

Site Status

Cardiology Consultants

Topeka, Kansas, United States

Site Status

Cardiovascular Consultants of Kansas

Wichita, Kansas, United States

Site Status

Louisville Cardiology Medical Group P.S

Louisville, Kentucky, United States

Site Status

Medical Center Cardiologists P.S.C

Louisville, Kentucky, United States

Site Status

Louisville Cardiology Medical Group P.S

Louisville, Kentucky, United States

Site Status

Owensboro Heart and Vascular

Owensboro, Kentucky, United States

Site Status

Tchefuncte Cardiovascular Associates,

Covington, Louisiana, United States

Site Status

Heart Clinic of Louisiana

Marrero, Louisiana, United States

Site Status

Maryland Heart, PC

Bethesda, Maryland, United States

Site Status

Heart Center of Southern Maryland

Clinton, Maryland, United States

Site Status

Arundel Heart Associates

Glen Burnie, Maryland, United States

Site Status

Peninsula Cardiology

Salisbury, Maryland, United States

Site Status

Primary Care Specialists Inc

Ayer, Massachusetts, United States

Site Status

Merrimack Valley Cardiology

Chelmsford, Massachusetts, United States

Site Status

Harbor Medical AssociatesSo Weymouth

Weymouth, Massachusetts, United States

Site Status

Consultants in Cardiology

Farmington Hills, Michigan, United States

Site Status

Cardiovascular Consultants PC

Rochester, Michigan, United States

Site Status

Eastside Cardiology, Roseville

Roseville, Michigan, United States

Site Status

St. Paul Cardiology

Saint Paul, Minnesota, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Missouri Cardiovascular Specialists

Columbia, Missouri, United States

Site Status

University Hospital Healthcare

Columbia, Missouri, United States

Site Status

Freeman Heart Institute

Joplin, Missouri, United States

Site Status

Mercy Cardiology

St Louis, Missouri, United States

Site Status

Cardiology Diagnostics, Ltd,

St Louis, Missouri, United States

Site Status

Cardiac Associates of New Hampshire

Concord, New Hampshire, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Medicor

Bridgewater, New Jersey, United States

Site Status

Cross County Cardiology

Edgewater, New Jersey, United States

Site Status

Heart-Lung Center

Hawthorne, New Jersey, United States

Site Status

Southern New Jersey Cardiac Specialists

Voorhees Township, New Jersey, United States

Site Status

Diagnostic and Clinical Cardiologists

West Orange, New Jersey, United States

Site Status

Westwood Cardiology

Westwood, New Jersey, United States

Site Status

Albany Associates in Cardiology,

Albany, New York, United States

Site Status

SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status

Cardiology Associates of Brooklyn

Brooklyn, New York, United States

Site Status

United Medical Associates

Brooklyn, New York, United States

Site Status

Concorde Medical Group/NYU Hospital

Manhattan, New York, United States

Site Status

Island Cardiac Specialists

Mineola, New York, United States

Site Status

Island Cardiac Specialist

Mineola, New York, United States

Site Status

Gotham Cardiovascular Research

New York, New York, United States

Site Status

Westchester Medical Group

Scarsdale, New York, United States

Site Status

Vazzana and Bogin Cardiology Associates

Staten Island, New York, United States

Site Status

Cardiology PC

Syracuse, New York, United States

Site Status

Southbay Cardiology

West Islip, New York, United States

Site Status

Asheville Cardiology Associates

Asheville, North Carolina, United States

Site Status

Sanger Clinic

Charlotte, North Carolina, United States

Site Status

Carolina Heart Specialists

Gastonia, North Carolina, United States

Site Status

Southeastern Heart and Vascular

Greensboro, North Carolina, United States

Site Status

Hickory Cardiology

Hickory, North Carolina, United States

Site Status

Carolina Cardiology Associates

High Point, North Carolina, United States

Site Status

Heart Center of Eastern Carolina,

New Bern, North Carolina, United States

Site Status

Heart Center of Eastern Carolina

New Bern, North Carolina, United States

Site Status

Pinehurst Cardiology Consultants

Pinehurst, North Carolina, United States

Site Status

Pinehurst Cardiology Consultants

Pinehurst, North Carolina, United States

Site Status

Raleigh Cardiology

Raleigh, North Carolina, United States

Site Status

Meritcare Medical Center

Fargo, North Dakota, United States

Site Status

Northeast Ohio Cardiovascular Specialists

Akron, Ohio, United States

Site Status

Muhammed H. Zahra

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Doctors Hospital Heart Failure Clinic

Columbus, Ohio, United States

Site Status

Schuster Cardiology Associates

Kettering, Ohio, United States

Site Status

The Heart Institute of Northwest Ohio

Lima, Ohio, United States

Site Status

Bryce Morrice MD and Debra Heldman MD Inc

Newark, Ohio, United States

Site Status

Cardiovascular Clinic, Inc.

Parma, Ohio, United States

Site Status

North West Ohio Cardiology Consultants

Toledo, Ohio, United States

Site Status

Abington Medical Specialists

Abington, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Central Bucks Specialists, Ltd.,

Doylestown, Pennsylvania, United States

Site Status

Associated Cardiologists

Harrisburg, Pennsylvania, United States

Site Status

The Heart Group, Ltd

Lancaster, Pennsylvania, United States

Site Status

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Cardiology Associates of Southeastern PA

Wynnewood, Pennsylvania, United States

Site Status

York Hospital

York, Pennsylvania, United States

Site Status

Blackstone Cardiology Associates

Pawtucket, Rhode Island, United States

Site Status

Medical University of South

Charleston, South Carolina, United States

Site Status

Upstate Cardiology

Greenville, South Carolina, United States

Site Status

Cardiology Associates

Myrtle Beach, South Carolina, United States

Site Status

Cardiology Consultants, PA

Spartanburg, South Carolina, United States

Site Status

Sumter Medical Consultants

Sumter, South Carolina, United States

Site Status

Columbia Cardiology Consultants

West Columbia, South Carolina, United States

Site Status

Sutherland Clinic

Germantown, Tennessee, United States

Site Status

Dela Clinic

Lexington, Tennessee, United States

Site Status

Heart Place North Arlington

Arlington, Texas, United States

Site Status

University of Texas South Western Medical Center at Dallas

Dallas, Texas, United States

Site Status

Comprehensive Heart Care, PA

Houston, Texas, United States

Site Status

Cardiology Consultants of Houston

Houston, Texas, United States

Site Status

Legacy Heart Center

Plano, Texas, United States

Site Status

Cardiology Clinic of San Antonio

San Antonio, Texas, United States

Site Status

Wilford Hall Medical Center

San Antonio, Texas, United States

Site Status

Tyler Cardiovascular Consultants

Tyler, Texas, United States

Site Status

University Associates in Cardiology

Burlington, Vermont, United States

Site Status

Cardiology Associates of Lakeview

Fairfax, Virginia, United States

Site Status

The Cardiovascular Group

Fairfax, Virginia, United States

Site Status

Tidewater Heart Specialists, Inc.,

Hampton, Virginia, United States

Site Status

Cardiology Associates of Green Bay

Green Bay, Wisconsin, United States

Site Status

Countries

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United States

References

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Shukla A, Curtis AB, Mehra MR, Albert NM, Gheorghiade M, Heywood JT, Liu Y, O'Connor CM, Reynolds D, Walsh MN, Yancy CW, Fonarow GC. Factors associated with improvement in utilization of cardiac resynchronization therapy in eligible heart failure patients: findings from IMPROVE HF. Pacing Clin Electrophysiol. 2013 Apr;36(4):433-43. doi: 10.1111/pace.12090. Epub 2013 Feb 4.

Reference Type DERIVED
PMID: 23380000 (View on PubMed)

Barkoudah E, Skali H, Uno H, Solomon SD, Pfeffer MA. Mortality rates in trials of subjects with type 2 diabetes. J Am Heart Assoc. 2012 Feb;1(1):8-15. doi: 10.1161/JAHA.111.000059. Epub 2012 Feb 20.

Reference Type DERIVED
PMID: 23130114 (View on PubMed)

Reynolds D, Albert NM, Curtis AB, Gheorghiade M, Heywood JT, Mcbride ML, Inge PJ, Mehra MR, O'Connor CM, Walsh MN, Yancy CW, Fonarow GC. Race and improvements in the use of guideline-recommended therapies for patients with heart failure: findings from IMPROVE HF. J Natl Med Assoc. 2012 May-Jun;104(5-6):287-98. doi: 10.1016/s0027-9684(15)30156-5.

Reference Type DERIVED
PMID: 22973678 (View on PubMed)

Fonarow GC, Albert NM, Curtis AB, Gheorghiade M, Heywood JT, Liu Y, Mehra MR, O'Connor CM, Reynolds D, Walsh MN, Yancy CW. Associations between outpatient heart failure process-of-care measures and mortality. Circulation. 2011 Apr 19;123(15):1601-10. doi: 10.1161/CIRCULATIONAHA.110.989632. Epub 2011 Apr 4.

Reference Type DERIVED
PMID: 21464053 (View on PubMed)

Walsh MN, Yancy CW, Albert NM, Curtis AB, Gheorghiade M, Heywood JT, Inge PJ, McBride ML, Mehra MR, O'Connor CM, Reynolds D, Fonarow GC. Equitable improvement for women and men in the use of guideline-recommended therapies for heart failure: findings from IMPROVE HF. J Card Fail. 2010 Dec;16(12):940-9. doi: 10.1016/j.cardfail.2010.07.250.

Reference Type DERIVED
PMID: 21111983 (View on PubMed)

Fonarow GC, Albert NM, Curtis AB, Stough WG, Gheorghiade M, Heywood JT, McBride ML, Inge PJ, Mehra MR, O'Connor CM, Reynolds D, Walsh MN, Yancy CW. Improving evidence-based care for heart failure in outpatient cardiology practices: primary results of the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF). Circulation. 2010 Aug 10;122(6):585-96. doi: 10.1161/CIRCULATIONAHA.109.934471. Epub 2010 Jul 26.

Reference Type DERIVED
PMID: 20660805 (View on PubMed)

Heywood JT, Fonarow GC, Yancy CW, Albert NM, Curtis AB, Gheorghiade M, Inge PJ, McBride ML, Mehra MR, O'Connor CM, Reynolds D, Walsh MN. Comparison of medical therapy dosing in outpatients cared for in cardiology practices with heart failure and reduced ejection fraction with and without device therapy: report from IMPROVE HF. Circ Heart Fail. 2010 Sep;3(5):596-605. doi: 10.1161/CIRCHEARTFAILURE.109.912683. Epub 2010 Jul 15.

Reference Type DERIVED
PMID: 20634483 (View on PubMed)

Walsh MN, Yancy CW, Albert NM, Curtis AB, Stough WG, Gheorghiade M, Heywood JT, McBride ML, Mehra MR, O'Connor CM, Reynolds D, Fonarow GC. Electronic health records and quality of care for heart failure. Am Heart J. 2010 Apr;159(4):635-642.e1. doi: 10.1016/j.ahj.2010.01.006.

Reference Type DERIVED
PMID: 20362723 (View on PubMed)

Mehra MR, Yancy CW, Albert NM, Curtis AB, Stough WG, Gheorghiade M, Heywood JT, McBride ML, O'Connor CM, Reynolds D, Walsh MN, Fonarow GC. Evidence of clinical practice heterogeneity in the use of implantable cardioverter-defibrillators in heart failure and post-myocardial infarction left ventricular dysfunction: Findings from IMPROVE HF. Heart Rhythm. 2009 Dec;6(12):1727-34. doi: 10.1016/j.hrthm.2009.08.022. Epub 2009 Aug 22.

Reference Type DERIVED
PMID: 19959119 (View on PubMed)

Curtis AB, Yancy CW, Albert NM, Stough WG, Gheorghiade M, Heywood JT, McBride ML, Mehra MR, Oconnor CM, Reynolds D, Walsh MN, Fonarow GC. Cardiac resynchronization therapy utilization for heart failure: findings from IMPROVE HF. Am Heart J. 2009 Dec;158(6):956-64. doi: 10.1016/j.ahj.2009.10.011.

Reference Type DERIVED
PMID: 19958862 (View on PubMed)

Other Identifiers

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258

Identifier Type: -

Identifier Source: org_study_id

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