NCT00344513

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

Completed Phase 4 Last updated 24 November 2020

What this trial tests

Phase 4 trial testing Beta-blockers including Carvedilol in Heart Failure, Congestive in 50,000 participants. Completed in 30 June 2005.

Timeline

16 December 2002

30 June 2005

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50,000
Start date	16 December 2002
Estimated completion	30 June 2005

Drugs / interventions tested

• Beta-blockers including Carvedilol — full drug profile →
• ACE inhibitors — full drug profile →

Conditions studied

• Heart Failure, Congestive — all drugs for Heart Failure, Congestive →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Eligibility, any sex, with Heart Failure, Congestive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Characteristics, treatments, and outcomes of patients with preserved systolic function hospitalized for heart failure: a report from the OPTIMIZE-HF Registry.
   Fonarow GC, Stough WG, Abraham WT, Albert NM, et al · · 2007 · cited 764× · PMID 17707182 · DOI 10.1016/j.jacc.2007.04.064
2. Relationship between early physician follow-up and 30-day readmission among Medicare beneficiaries hospitalized for heart failure.
   Hernandez AF, Greiner MA, Fonarow GC, Hammill BG, et al · · 2010 · cited 751× · PMID 20442387 · DOI 10.1001/jama.2010.533
3. Factors identified as precipitating hospital admissions for heart failure and clinical outcomes: findings from OPTIMIZE-HF.
   Fonarow GC, Abraham WT, Albert NM, Stough WG, et al · · 2008 · cited 361× · PMID 18443260 · DOI 10.1001/archinte.168.8.847
4. Linking inpatient clinical registry data to Medicare claims data using indirect identifiers.
   Hammill BG, Hernandez AF, Peterson ED, Fonarow GC, et al · · 2009 · cited 334× · PMID 19464409 · DOI 10.1016/j.ahj.2009.04.002
5. 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).
   Fonarow GC, Abraham WT, Albert NM, Gattis Stough W, et al · · 2007 · cited 209× · PMID 17646603 · DOI 10.1001/archinte.167.14.1493
6. Influence of beta-blocker continuation or withdrawal on outcomes in patients hospitalized with heart failure: findings from the OPTIMIZE-HF program.
   Fonarow GC, Abraham WT, Albert NM, Stough WG, et al · · 2008 · cited 153× · PMID 18617067 · DOI 10.1016/j.jacc.2008.03.048
7. Representativeness of a national heart failure quality-of-care registry: comparison of OPTIMIZE-HF and non-OPTIMIZE-HF Medicare patients.
   Curtis LH, Greiner MA, Hammill BG, DiMartino LD, et al · · 2009 · cited 82× · PMID 20031864 · DOI 10.1161/circoutcomes.108.822692
8. Clinical effectiveness of implantable cardioverter-defibrillators among medicare beneficiaries with heart failure.
   Hernandez AF, Fonarow GC, Hammill BG, Al-Khatib SM, et al · · 2010 · cited 56× · PMID 20009044 · DOI 10.1161/circheartfailure.109.884395