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Heart Failure, CongestiveIMPROVE-HFNCT00303979

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

An observational study of Heart Failure, Congestive and Myocardial Infarction, run by Medtronic Cardiac Rhythm and Heart Failure at 144 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
34,810 participants
Where
144 sitesUnited States
Study dates
May 2005to Aug 2009
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Heart failure patients in outpatient cardiology practices

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

144 sites in 1 country.

144 sites in 1 country

United States144 sites

  • Abington Medical Specialists

    Abington, Pennsylvania, 19001

  • Northeast Ohio Cardiovascular Specialists

    Akron, Ohio, 44301

  • Albany Associates in Cardiology,

    Albany, New York, 12205

  • Heart Place North Arlington

    Arlington, Texas, 75284

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28803

  • Cardiology of Atlanta

    Atlanta, Georgia, 30342

  • Northside Cardiology

    Atlanta, Georgia, 30342

  • Primary Care Specialists Inc

    Ayer, Massachusetts, 01432

  • Maryland Heart, PC

    Bethesda, Maryland, 20817

  • Cardiovascular Associates of Montclair

    Birmingham, Alabama, 36608

  • Heart Care Center of Illinois

    Blue Island, Illinois, 60406

  • St. Luke's Idaho Cardiology Associates

    Boise, Idaho, 83702

  • Heart and Vascular Center of Bradenton

    Bradenton, Florida, 34209

  • Connecticut Heart & Vascular Center

    Bridgeport, Connecticut, 06606

  • Medicor

    Bridgewater, New Jersey, 08807

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Cardiology Associates of Brooklyn

    Brooklyn, New York, 11219

  • United Medical Associates

    Brooklyn, New York, 11219

  • University Associates in Cardiology

    Burlington, Vermont, 05401

  • Medical University of South

    Charleston, South Carolina, 29406

  • Sanger Clinic

    Charlotte, North Carolina, 28202

  • Merrimack Valley Cardiology

    Chelmsford, Massachusetts, 01824

  • Clearwater Cardiovascular & Intervention

    Clearwater, Florida, 33756

  • Mahesh Amin, MD PA

    Clearwater, Florida, 33756

  • Muhammed H. Zahra

    Cleveland, Ohio, 44125

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Heart Center of Southern Maryland

    Clinton, Maryland, 20735

  • Missouri Cardiovascular Specialists

    Columbia, Missouri, 65201

  • University Hospital Healthcare

    Columbia, Missouri, 65210

  • Doctors Hospital Heart Failure Clinic

    Columbus, Ohio, 43228

  • Cardiac Associates of New Hampshire

    Concord, New Hampshire, 03303

  • Tchefuncte Cardiovascular Associates,

    Covington, Louisiana, 70433

  • University of Texas South Western Medical Center at Dallas

    Dallas, Texas, 75201

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Central Bucks Specialists, Ltd.,

    Doylestown, Pennsylvania, 18901

  • Cross County Cardiology

    Edgewater, New Jersey, 07020

  • Cardiology Associates of Lakeview

    Fairfax, Virginia, 05454

  • The Cardiovascular Group

    Fairfax, Virginia, 22031

  • Meritcare Medical Center

    Fargo, North Dakota, 58122

  • Consultants in Cardiology

    Farmington Hills, Michigan, 48331

  • Medical Center of the Rockies

    Fort Collins, Colorado, 80521

  • MidAmerica Cardiovascular Consultants

    Frankfort, Illinois, 60453

  • St. Jude Heritage Medical Group

    Fullerton, California, 92835

  • Northeast Georgia Heart Center

    Gainesville, Georgia, 30501

  • Carolina Heart Specialists

    Gastonia, North Carolina, 28054

  • Sutherland Clinic

    Germantown, Tennessee, 38119

  • Arundel Heart Associates

    Glen Burnie, Maryland, 21061

  • Cardiovascular Associates of Glenbrook and Evanston, LLC

    Glenview, Illinois, 60026

  • Cardiology Associates of Green Bay

    Green Bay, Wisconsin, 54301

  • Southeastern Heart and Vascular

    Greensboro, North Carolina, 27403

  • Upstate Cardiology

    Greenville, South Carolina, 29605

  • Tidewater Heart Specialists, Inc.,

    Hampton, Virginia, 23666

  • Associated Cardiologists

    Harrisburg, Pennsylvania, 17103

  • Heart-Lung Center

    Hawthorne, New Jersey, 07506-1919

  • Hickory Cardiology

    Hickory, North Carolina, 28602

  • Carolina Cardiology Associates

    High Point, North Carolina, 27262

  • Pacific Cardiology

    Honolulu, Hawaii, 96817

  • Central Arkansas Cardiovascular Institute

    Hot Springs, Arkansas, 71913

  • Comprehensive Heart Care, PA

    Houston, Texas, 77024

  • Cardiology Consultants of Houston

    Houston, Texas, 77030

  • Pasco Cardiology

    Hudson, Florida, 34667

  • St. Vincent's Hospital

    Indianapolis, Indiana, 46201

  • Methodist Hospital

    Indianapolis, Indiana, 46202

  • St. Vincent's Hospital Indianapolis

    Indianapolis, Indiana, 46278

  • St. Vincent's Hospital,

    Indianapolis, Indiana, 46278

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Freeman Heart Institute

    Joplin, Missouri, 64804

  • Mid America Cardiology

    Kansas City, Kansas, 66102

  • Schuster Cardiology Associates

    Kettering, Ohio, 45336

  • Cardiovascular Associates

    Kissimmee, Florida, 34741

  • Scripps Clinic Green Hospital

    La Jolla, California, 92037

  • Clark and Daughtrey Medical Group

    Lakeland, Florida, 33803

  • The Heart Group, Ltd

    Lancaster, Pennsylvania, 17603

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

  • Dela Clinic

    Lexington, Tennessee, 38351

  • The Heart Institute of Northwest Ohio

    Lima, Ohio, 45801

  • Arkansas Cardiology Clinic

    Little Rock, Arkansas, 72202

  • Veterans Administration Hospital

    Los Angeles, California, 92357

  • University Cardiovascular Medical Group

    Los Angeles, California, 94115

  • Louisville Cardiology Medical Group P.S

    Louisville, Kentucky, 40026

  • Medical Center Cardiologists P.S.C

    Louisville, Kentucky, 40201

  • Louisville Cardiology Medical Group P.S

    Louisville, Kentucky, 40207

  • Concorde Medical Group/NYU Hospital

    Manhattan, New York, 10001

  • Heart Clinic of Louisiana

    Marrero, Louisiana, 70072

  • OMNI

    Melbourne, Florida, 32901

  • Cardiovascular Associates of Mesa

    Mesa, Arizona, 85205

  • Miami Cardiology Group

    Miami, Florida, 33176

  • Island Cardiac Specialists

    Mineola, New York, 11501

  • Island Cardiac Specialist

    Mineola, New York, 11501

  • Cardiology Associates

    Mobile, Alabama, 36608

  • Cardio-Pulmonary Associates

    Monterey, California, 93940

  • Temecula Valley Cardiology

    Murrieta, California, 92562

  • Cardiology Associates

    Myrtle Beach, South Carolina, 29572

  • Heart Center of Eastern Carolina,

    New Bern, North Carolina, 28562

  • Heart Center of Eastern Carolina

    New Bern, North Carolina, 28562

  • Gotham Cardiovascular Research

    New York, New York, 10001

  • Cardiology Consultants, PA

    Newark, Delaware, 19702

  • Bryce Morrice MD and Debra Heldman MD Inc

    Newark, Ohio, 43055

  • Florida Heart Group

    Orlando, Florida, 32803

  • Owensboro Heart and Vascular

    Owensboro, Kentucky, 42303

  • Cardiovascular Clinic, Inc.

    Parma, Ohio, 44129

  • Blackstone Cardiology Associates

    Pawtucket, Rhode Island, 02860

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19129

  • Pinehurst Cardiology Consultants

    Pinehurst, North Carolina, 28370

  • Pinehurst Cardiology Consultants

    Pinehurst, North Carolina, 28374

  • Legacy Heart Center

    Plano, Texas, 75024

  • Cardiology Associates

    Port Charlotte, Florida, 33952

  • Raleigh Cardiology

    Raleigh, North Carolina, 27610

  • Cardiovascular Consultants PC

    Rochester, Michigan, 48312

  • Eastside Cardiology, Roseville

    Roseville, Michigan, 48066

  • St. Paul Cardiology

    Saint Paul, Minnesota, 55102

  • Peninsula Cardiology

    Salisbury, Maryland, 21804

  • Cardiology Clinic of San Antonio

    San Antonio, Texas, 78229

  • Wilford Hall Medical Center

    San Antonio, Texas, 78229

  • California Pacific Cardiovascular Medical

    San Francisco, California, 94115

  • East Bay Cardiology

    San Pablo, California, 94803

  • Southcoast Cardiology

    Savannah, Georgia, 31406

  • Westchester Medical Group

    Scarsdale, New York, 10583

  • Heart Care, PC

    Scottsdale, Arizona, 85258

  • Cardiology Consultants, PA

    Spartanburg, South Carolina, 29301

  • Mercy Cardiology

    St Louis, Missouri, 63101

  • Cardiology Diagnostics, Ltd,

    St Louis, Missouri, 63131

  • Vazzana and Bogin Cardiology Associates

    Staten Island, New York, 10305

  • Sumter Medical Consultants

    Sumter, South Carolina, 29150

  • Cardiology PC

    Syracuse, New York, 13210

  • Cardiovascular Consultants,

    Tamarac, Florida, 33309

  • Cardiology Consultants Medical Group

    Tarzana, California, 91335

  • North West Ohio Cardiology Consultants

    Toledo, Ohio, 43615

  • Cardiology Consultants

    Topeka, Kansas, 66102

  • Southern Arizona VA Health Care System

    Tucson, Arizona, 85723

  • Tyler Cardiovascular Consultants

    Tyler, Texas, 75701

  • Indian River Cardiovascular Associate

    Vero Beach, Florida, 32960

  • Southern New Jersey Cardiac Specialists

    Voorhees Township, New Jersey, 08043

  • Columbia Cardiology Consultants

    West Columbia, South Carolina, 29204

  • Iowa Heart Center PC,

    West Des Moines, Iowa, 50266

  • Southbay Cardiology

    West Islip, New York, 11795

  • Diagnostic and Clinical Cardiologists

    West Orange, New Jersey, 07052

  • Westwood Cardiology

    Westwood, New Jersey, 07675

  • Harbor Medical AssociatesSo Weymouth

    Weymouth, Massachusetts, 02190

  • Cardiovascular Consultants of Kansas

    Wichita, Kansas, 67226

  • Cardiology Associates of Southeastern PA

    Wynnewood, Pennsylvania, 19064

  • York Hospital

    York, Pennsylvania, 17403

  • Florida Medical Clinic

    Zephyrhills, Florida, 33542

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Keywords
Systolic Heart Failure, Quality of Care, Outcomes, Evidence-based Guidelines, Recommended Therapies
Medical subject headings
Heart Failure, Myocardial Infarction, Ventricular Dysfunction, Left, Heart Failure, Systolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00303979
Study groupRoleWhat they receive
Cohort A (longitudinal)Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months
Cohort B (6 Month)6 Month Cohort: Approximately 10,000 patients reviewed at single time point
Cohort C (18 Month)18 Month Cohort: Approximately 10,000 patients reviewed at single time point

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To Evaluate Over the Aggregate IMPROVE-HF Practice Sites the Relative Changes in 7 Performance Measures at 24 Months Compared With Baseline and Determine the Number of Performance Measures That Achieved a Relative 20% or Greater Positive Change.

    7 performance measures: angiotensin converting enzyme inhibitor and/or angiotensin II receptor blockers (ACEI/ARB), beta-blokers, aldosterone receptor antagonists, anticoagulation for atrial fibrillation (AF), cardiac resynchronization therapy (CRT-P/CRT-D), cardioverter-defibrillator (ICD/CRT-D), heart failure (HF) education.

    We first calcuated % of patients who were eligible for a performance measure that were treated by it at baseline and 24 months. We then calculated the relative change as (% treated at 24 months - % treated at baseline)/% treated at baseline. The 95% confidence interval (CI) was calculated and the relative change of each performance measure was evaluated using a z-test for one-sample proportion.

    The number of performance measures with >= 20% relative improvement was determined. The intervention was considered successful if a relative 20% or greater improvement in at least 2 of the 7 performance measures at 24 months compared with baseline was achieved.

    Measured: 24 Month

Secondary outcomes (4)

  1. Observe the Number of Sites That Demonstrate a Relative 20% or Greater Improvement in 2 or More of the 7 Performance Measures at 24 Months as Compared to Baseline in Cohort A.

    The number of practices that achieved greater than or equal to 20% improvement in two or more of the 7 performance measures at 24 months as compared to baseline of cohort A is presented.

    Measured: 24 months

  2. Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices.

    performance measure improvement for each performance measure was analyzed at a practice level from baseline to 24 months. Performance measure adherence was calculated at the individual practice level and then combined and summarized. Mean, standard deviation, and 95% confidence intervals for performance measure adherence, composite score and relative change (24 months compared with baseline) are reported.

    The Composite Score is based on the ratio of the sum of the numerators of all individual performance measures to the sum of the denominators of all individual performances measures. The numerator of a performance measure is the number of patients treated with that measure. The denomiator of a performance measure is the number of patients eligible for being treated with that measure.

    Measured: 24 months

  3. Observe the Relative Change Between Baseline of Cohort A and 6 Months of Cohort B in Performance Measures and Composite Score for the Aggregate Practices.

    The relative changes between baseline of cohort A and 6 months of cohort B in performance measures and composite score for the aggregate practices were calculated using mean, standard deviation and 95% CI.

    Measured: Baseline and 6 Months

  4. Observe the Relative Change Between Baseline of Cohort A and 18 Months of Cohort C in Performance Measures and Composite Score for the Aggregate Practices.

    The relative changes between baseline of cohort A and 18 months of cohort C in performance measures and composite score for the aggregate practices were calculated using mean, standard deviation and 95% CI.

    Measured: baseline and 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2006 (estimated)
  2. Study startMay 2005
  3. Primary completionAug 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
34,810 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303979
Sponsor's protocol ID
258
Acronym
IMPROVE-HF
Status last verified
Jan 2019
First submitted
15 Mar 2006
Last updated
31 Jan 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 23380000

  • 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.

    PubMed 23130114

  • 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.

    PubMed 22973678

  • 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.

    PubMed 21464053

  • 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.

    PubMed 21111983

  • 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.

    PubMed 20660805

  • 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.

    PubMed 20634483

  • 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.

    PubMed 20362723

  • 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.

    PubMed 19959119

  • 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.

    PubMed 19958862

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, Congestive and Myocardial Infarction, run by Medtronic Cardiac Rhythm and Heart Failure at 144 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Evaluate Over the Aggregate IMPROVE-HF Practice Sites the Relative Changes in 7 Performance Measures at 24 Months Compared With Baseline and Determine the Number of Performance Measures That Achieved a Relative 20% or Greater Positive Change. (time frame: 24 Month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00303979, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.

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