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

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Beta-blockers including Carvedilol
ACE inhibitors
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive focused on measuring registry, OPTIMIZE, Heart failure, OPTIMIZE-HF

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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 Measures

    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.

    Full Information

    First Posted
    June 23, 2006
    Last Updated
    November 20, 2020
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00344513
    Brief Title
    Organized Program To Initiate Lifesaving Treatment In Hospitalized Patients With Heart Failure (OPTIMIZE-HF)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 16, 2002 (Actual)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 30, 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Congestive
    Keywords
    registry, OPTIMIZE, Heart failure, OPTIMIZE-HF

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50000 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Beta-blockers including Carvedilol
    Intervention Type
    Drug
    Intervention Name(s)
    ACE inhibitors
    Other Intervention Name(s)
    Beta-blockers including Carvedilol
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24703206
    Citation
    Patel K, Fonarow GC, Ekundayo OJ, Aban IB, Kilgore ML, Love TE, Kitzman DW, Gheorghiade M, Allman RM, Ahmed A. Beta-blockers in older patients with heart failure and preserved ejection fraction: class, dosage, and outcomes. Int J Cardiol. 2014 May 15;173(3):393-401. doi: 10.1016/j.ijcard.2014.03.005. Epub 2014 Mar 11.
    Results Reference
    derived
    PubMed Identifier
    23200803
    Citation
    Mentz RJ, Wojdyla D, Fiuzat M, Chiswell K, Fonarow GC, O'Connor CM. Association of beta-blocker use and selectivity with outcomes in patients with heart failure and chronic obstructive pulmonary disease (from OPTIMIZE-HF). Am J Cardiol. 2013 Feb 15;111(4):582-7. doi: 10.1016/j.amjcard.2012.10.041. Epub 2012 Nov 29.
    Results Reference
    derived
    PubMed Identifier
    20598983
    Citation
    Patel UD, Greiner MA, Fonarow GC, Phatak H, Hernandez AF, Curtis LH. Associations between worsening renal function and 30-day outcomes among Medicare beneficiaries hospitalized with heart failure. Am Heart J. 2010 Jul;160(1):132-138.e1. doi: 10.1016/j.ahj.2010.03.033.
    Results Reference
    derived
    PubMed Identifier
    20442387
    Citation
    Hernandez AF, Greiner MA, Fonarow GC, Hammill BG, Heidenreich PA, Yancy CW, Peterson ED, Curtis LH. Relationship between early physician follow-up and 30-day readmission among Medicare beneficiaries hospitalized for heart failure. JAMA. 2010 May 5;303(17):1716-22. doi: 10.1001/jama.2010.533.
    Results Reference
    derived
    PubMed Identifier
    20211302
    Citation
    Hernandez AF, Hammill BG, Peterson ED, Yancy CW, Schulman KA, Curtis LH, Fonarow GC. Relationships between emerging measures of heart failure processes of care and clinical outcomes. Am Heart J. 2010 Mar;159(3):406-13. doi: 10.1016/j.ahj.2009.12.024.
    Results Reference
    derived
    PubMed Identifier
    20152220
    Citation
    Levy PD, Nandyal D, Welch RD, Sun JL, Pieper K, Ghali JK, Fonarow GC, Gheorghiade M, O'Connor CM. Does aspirin use adversely influence intermediate-term postdischarge outcomes for hospitalized patients who are treated with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers? Findings from Organized Program to Facilitate Life-Saving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF). Am Heart J. 2010 Feb;159(2):222-230.e2. doi: 10.1016/j.ahj.2009.11.009. Erratum In: Am Heart J. 2010 Jul;160(1):208.
    Results Reference
    derived
    PubMed Identifier
    20009044
    Citation
    Hernandez AF, Fonarow GC, Hammill BG, Al-Khatib SM, Yancy CW, O'Connor CM, Schulman KA, Peterson ED, Curtis LH. Clinical effectiveness of implantable cardioverter-defibrillators among medicare beneficiaries with heart failure. Circ Heart Fail. 2010 Jan;3(1):7-13. doi: 10.1161/CIRCHEARTFAILURE.109.884395. Epub 2009 Dec 15.
    Results Reference
    derived
    PubMed Identifier
    19576329
    Citation
    Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy C, Young JB; OPTIMIZE-HF Investigators and Hospitals. Age- and gender-related differences in quality of care and outcomes of patients hospitalized with heart failure (from OPTIMIZE-HF). Am J Cardiol. 2009 Jul 1;104(1):107-15. doi: 10.1016/j.amjcard.2009.02.057.
    Results Reference
    derived
    PubMed Identifier
    19464412
    Citation
    Flaherty JD, Rossi JS, Fonarow GC, Nunez E, Stough WG, Abraham WT, Albert NM, Greenberg BH, O'Connor CM, Yancy CW, Young JB, Davidson CJ, Gheorghiade M. Influence of coronary angiography on the utilization of therapies in patients with acute heart failure syndromes: findings from Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF). Am Heart J. 2009 Jun;157(6):1018-25. doi: 10.1016/j.ahj.2009.03.011. Epub 2009 Apr 23.
    Results Reference
    derived
    PubMed Identifier
    19464409
    Citation
    Hammill BG, Hernandez AF, Peterson ED, Fonarow GC, Schulman KA, Curtis LH. Linking inpatient clinical registry data to Medicare claims data using indirect identifiers. Am Heart J. 2009 Jun;157(6):995-1000. doi: 10.1016/j.ahj.2009.04.002.
    Results Reference
    derived
    PubMed Identifier
    18926148
    Citation
    O'Connor CM, Abraham WT, Albert NM, Clare R, Gattis Stough W, Gheorghiade M, Greenberg BH, Yancy CW, Young JB, Fonarow GC. Predictors of mortality after discharge in patients hospitalized with heart failure: an analysis from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF). Am Heart J. 2008 Oct;156(4):662-73. doi: 10.1016/j.ahj.2008.04.030.
    Results Reference
    derived
    PubMed Identifier
    18652942
    Citation
    Abraham WT, Fonarow GC, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB; OPTIMIZE-HF Investigators and Coordinators. Predictors of in-hospital mortality in patients hospitalized for heart failure: insights from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF). J Am Coll Cardiol. 2008 Jul 29;52(5):347-56. doi: 10.1016/j.jacc.2008.04.028.
    Results Reference
    derived
    PubMed Identifier
    18617067
    Citation
    Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB; OPTIMIZE-HF Investigators and Coordinators. Influence of beta-blocker continuation or withdrawal on outcomes in patients hospitalized with heart failure: findings from the OPTIMIZE-HF program. J Am Coll Cardiol. 2008 Jul 15;52(3):190-9. doi: 10.1016/j.jacc.2008.03.048.
    Results Reference
    derived
    PubMed Identifier
    18487210
    Citation
    Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Nunez E, Yancy CW, Young JB. A smoker's paradox in patients hospitalized for heart failure: findings from OPTIMIZE-HF. Eur Heart J. 2008 Aug;29(16):1983-91. doi: 10.1093/eurheartj/ehn210. Epub 2008 May 15.
    Results Reference
    derived
    PubMed Identifier
    19808270
    Citation
    Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Nunez E, Yancy CW, Young JB. Day of admission and clinical outcomes for patients hospitalized for heart failure: findings from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure (OPTIMIZE-HF). Circ Heart Fail. 2008 May;1(1):50-7. doi: 10.1161/CIRCHEARTFAILURE.107.748376.
    Results Reference
    derived
    PubMed Identifier
    18443260
    Citation
    Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Pieper K, Sun JL, Yancy CW, Young JB; OPTIMIZE-HF Investigators and Hospitals. Factors identified as precipitating hospital admissions for heart failure and clinical outcomes: findings from OPTIMIZE-HF. Arch Intern Med. 2008 Apr 28;168(8):847-54. doi: 10.1001/archinte.168.8.847.
    Results Reference
    derived
    PubMed Identifier
    18436120
    Citation
    Yancy CW, Abraham WT, Albert NM, Clare R, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, She L, Sun JL, Young JB, Fonarow GC. Quality of care of and outcomes for African Americans hospitalized with heart failure: findings from the OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure) registry. J Am Coll Cardiol. 2008 Apr 29;51(17):1675-84. doi: 10.1016/j.jacc.2008.01.028.
    Results Reference
    derived
    PubMed Identifier
    18178411
    Citation
    Young JB, Abraham WT, Albert NM, Gattis Stough W, Gheorghiade M, Greenberg BH, O'Connor CM, She L, Sun JL, Yancy CW, Fonarow GC; OPTIMIZE-HF Investigators and Coordinators. Relation of low hemoglobin and anemia to morbidity and mortality in patients hospitalized with heart failure (insight from the OPTIMIZE-HF registry). Am J Cardiol. 2008 Jan 15;101(2):223-30. doi: 10.1016/j.amjcard.2007.07.067.
    Results Reference
    derived
    PubMed Identifier
    17996820
    Citation
    Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB; OPTIMIZE-HF Investigators and Coordinators. Prospective evaluation of beta-blocker use at the time of hospital discharge as a heart failure performance measure: results from OPTIMIZE-HF. J Card Fail. 2007 Nov;13(9):722-31. doi: 10.1016/j.cardfail.2007.06.727.
    Results Reference
    derived
    PubMed Identifier
    17707182
    Citation
    Fonarow GC, Stough WG, Abraham WT, Albert NM, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB; OPTIMIZE-HF Investigators and Hospitals. Characteristics, treatments, and outcomes of patients with preserved systolic function hospitalized for heart failure: a report from the OPTIMIZE-HF Registry. J Am Coll Cardiol. 2007 Aug 21;50(8):768-77. doi: 10.1016/j.jacc.2007.04.064. Epub 2007 Aug 6.
    Results Reference
    derived
    PubMed Identifier
    17646603
    Citation
    Fonarow GC, Abraham WT, Albert NM, Gattis Stough W, Gheorghiade M, Greenberg BH, O'Connor CM, Pieper K, Sun JL, Yancy CW, Young JB; OPTIMIZE-HF Investigators and Hospitals. Influence of a performance-improvement initiative on quality of care for patients hospitalized with heart failure: results of the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure (OPTIMIZE-HF). Arch Intern Med. 2007 Jul 23;167(14):1493-502. doi: 10.1001/archinte.167.14.1493.
    Results Reference
    derived
    PubMed Identifier
    17643576
    Citation
    Greenberg BH, Abraham WT, Albert NM, Chiswell K, Clare R, Stough WG, Gheorghiade M, O'Connor CM, Sun JL, Yancy CW, Young JB, Fonarow GC. Influence of diabetes on characteristics and outcomes in patients hospitalized with heart failure: a report from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF). Am Heart J. 2007 Aug;154(2):277.e1-8. doi: 10.1016/j.ahj.2007.05.001. Erratum In: Am Heart J. 2007 Oct;154(4):646.
    Results Reference
    derived
    PubMed Identifier
    17448416
    Citation
    Albert NM, Fonarow GC, Abraham WT, Chiswell K, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB. Predictors of delivery of hospital-based heart failure patient education: a report from OPTIMIZE-HF. J Card Fail. 2007 Apr;13(3):189-98. doi: 10.1016/j.cardfail.2006.11.008.
    Results Reference
    derived
    PubMed Identifier
    17174643
    Citation
    Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy C, Young JB; OPTIMIZE-HF Investigators and Coordinators. Carvedilol use at discharge in patients hospitalized for heart failure is associated with improved survival: an analysis from Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF). Am Heart J. 2007 Jan;153(1):82.e1-11. doi: 10.1016/j.ahj.2006.10.008.
    Results Reference
    derived

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

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