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
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring registry, OPTIMIZE, Heart failure, OPTIMIZE-HF
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.
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
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
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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
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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
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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
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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
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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.
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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.
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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.
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PubMed Identifier
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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
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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
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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
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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
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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
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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.
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PubMed Identifier
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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Organized Program To Initiate Lifesaving Treatment In Hospitalized Patients With Heart Failure (OPTIMIZE-HF)
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