AzTrials
AzTrials

Heart Failure, CongestivePhase 4NCT00344513

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

A Phase 4 study testing Beta-blockers including Carvedilol and ACE inhibitors in people with Heart Failure, Congestive, run by GlaxoSmithKline.

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

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Heart Failure, Congestive
What is being tested?
Beta-blockers including Carvedilol and ACE inhibitors
How many people
50,000 participants
Where
No sites listed yet
Study dates
16 Dec 2002to 30 Jun 2005
Phase
Phase 4
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • This study has no exclusion criteria.

About this study

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

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.

Being tested
Beta-blockers including Carvedilol, ACE inhibitors
Keywords
registry, OPTIMIZE, Heart failure, OPTIMIZE-HF
Medical subject headings
Heart Failure

What participants receive

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

  • Beta-blockers including CarvedilolDrug

  • ACE inhibitorsDrug

    Also called Beta-blockers including Carvedilol

What is being measured

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

  1. Evaluate the number and percentage of eligible patients who are discharged on optimal therapy. Evaluate all HF indicators recommended by JCAHO and CMS.

Secondary outcomes (1)

  1. 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.

Timeline

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

  1. First posted26 Jun 2006 (estimated)
  2. Study start16 Dec 2002
  3. Study completion30 Jun 2005

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00344513
Sponsor's protocol ID
105517/358
Status last verified
Nov 2020
First submitted
23 Jun 2006
Last updated
24 Nov 2020
Results posted
No

Publications

  • 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.

    PubMed 24703206

  • 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.

    PubMed 23200803

  • 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.

    PubMed 20598983

  • 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.

    PubMed 20442387

  • 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.

    PubMed 20211302

  • 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.

    PubMed 20152220

  • 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.

    PubMed 20009044

  • 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.

    PubMed 19808270

  • 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.

    PubMed 19576329

  • 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.

    PubMed 19464412

  • 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.

    PubMed 19464409

  • 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.

    PubMed 18926148

  • 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.

    PubMed 18652942

  • 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.

    PubMed 18617067

  • 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.

    PubMed 18487210

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Beta-blockers including Carvedilol and ACE inhibitors in people with Heart Failure, Congestive, run by GlaxoSmithKline.

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 2 inclusion and 1 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evaluate the number and percentage of eligible patients who are discharged on optimal therapy. Evaluate all HF indicators recommended by JCAHO and CMS.. 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 NCT00344513, which also lists 24 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 24 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in