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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00344513

First received: June 23, 2006

Last updated: September 13, 2016

Last verified: September 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
Heart Failure, Congestive	Drug: Beta-blockers including Carvedilol Drug: ACE inhibitors	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Carvedilol Carvedilol hydrochloride Adrenergic beta-Antagonists

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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.


Estimated Enrollment:	50000
Study Start Date:	December 2002
Study Completion Date:	June 2005

Intervention Details:

Other Name: Beta-blockers including Carvedilol

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344513

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. This link exits the ClinicalTrials.gov site

Study Data/Documents: Clinical Study Report This link exits the ClinicalTrials.gov site

Identifier: 105517/358
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form This link exits the ClinicalTrials.gov site

Identifier: 105517/358
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification This link exits the ClinicalTrials.gov site

Identifier: 105517/358
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set This link exits the ClinicalTrials.gov site

Identifier: 105517/358
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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. Epub 2007 Aug 6.

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.

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. Erratum in: Am Heart J. 2007 Oct;154(4):646.

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.

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.


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00344513 History of Changes
Other Study ID Numbers:	105517/358
Study First Received:	June 23, 2006
Last Updated:	September 13, 2016
Health Authority:	United States: Food and Drug Administration
Individual Participant Data
Plan to Share IPD:	Yes
Plan Description:	Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:


registry OPTIMIZE Heart failure OPTIMIZE-HF

Additional relevant MeSH terms:


Heart Failure Heart Diseases Cardiovascular Diseases Carvedilol Adrenergic beta-Antagonists Angiotensin-Converting Enzyme Inhibitors Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents	Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antihypertensive Agents Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Protease Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016

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