NCT00000619

Brief Summary

To compare the efficacy of Pulmonary Artery Catheterization (PAC)-directed treatment strategy to a non-invasive treatment strategy on morbidity and mortality in patients with severe, class IV New York Heart Association (NYHA) congestive heart failure. A secondary objective was to determine costs and resource utilization of PAC-directed treatment strategy compared to non-invasive treatment strategy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 1, 2001

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

April 14, 2016

Status Verified

January 1, 2008

Enrollment Period

4.9 years

First QC Date

October 27, 1999

Last Update Submit

April 13, 2016

Conditions

Heart DiseasesHeart Failure, CongestiveHeart Failure

Interventions

catheterization, Swan-GanzPROCEDURE

Eligibility Criteria

Age16 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Patients ages over 16, with class IV congestive heart failure (CHF). Patients had current hospitalization for CHF, one previous hospitalization for CHF within the past six months, left ventricular ejection fraction \<35 percent for at least three months, and attempted therapy with angiotensin converting enzyme inhibitors (ACEI) and digoxin and/or diuretics in the past. Patients had NYHA class IV with clinical evidence of elevated filling pressures at rest, that is, (a) evidence of elevated intracardiac filling pressures: orthopnea, abdominal discomfort attributed to hepato-splenic congestion, peripheral edema, ascites, rales, and jugular venous distension to 5 cm or less above sternal angle; and (b) inadequate peripheral perfusion, that is, cool extremities. Exclusions included patients with acute CHF requiring PAC as a part of the management and factors suggesting inability to comply with the protocol.

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Sponsors & Collaborators

Related Publications (6)

  • Shah MR, O'Connor CM, Sopko G, Hasselblad V, Califf RM, Stevenson LW. Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE): design and rationale. Am Heart J. 2001 Apr;141(4):528-35. doi: 10.1067/mhj.2001.113995.

    PMID: 11275915BACKGROUND

  • Binanay C, Califf RM, Hasselblad V, O'Connor CM, Shah MR, Sopko G, Stevenson LW, Francis GS, Leier CV, Miller LW; ESCAPE Investigators and ESCAPE Study Coordinators. Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial. JAMA. 2005 Oct 5;294(13):1625-33. doi: 10.1001/jama.294.13.1625.

    PMID: 16204662BACKGROUND

  • Cooper LB, Mentz RJ, Stevens SR, Felker GM, Lombardi C, Metra M, Stevenson LW, O'Connor CM, Milano CA, Patel CB, Rogers JG. Hemodynamic Predictors of Heart Failure Morbidity and Mortality: Fluid or Flow? J Card Fail. 2016 Mar;22(3):182-9. doi: 10.1016/j.cardfail.2015.11.012. Epub 2015 Dec 15.

    PMID: 26703245DERIVED

  • Kalogeropoulos AP, Marti CN, Georgiopoulou VV, Butler J. Inotrope use and outcomes among patients hospitalized for heart failure: impact of systolic blood pressure, cardiac index, and etiology. J Card Fail. 2014 Aug;20(8):593-601. doi: 10.1016/j.cardfail.2014.05.006. Epub 2014 May 28.

    PMID: 24879975DERIVED

  • O'Connor CM, Hasselblad V, Mehta RH, Tasissa G, Califf RM, Fiuzat M, Rogers JG, Leier CV, Stevenson LW. Triage after hospitalization with advanced heart failure: the ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) risk model and discharge score. J Am Coll Cardiol. 2010 Mar 2;55(9):872-8. doi: 10.1016/j.jacc.2009.08.083.

    PMID: 20185037DERIVED

  • Nohria A, Hasselblad V, Stebbins A, Pauly DF, Fonarow GC, Shah M, Yancy CW, Califf RM, Stevenson LW, Hill JA. Cardiorenal interactions: insights from the ESCAPE trial. J Am Coll Cardiol. 2008 Apr 1;51(13):1268-74. doi: 10.1016/j.jacc.2007.08.072.

    PMID: 18371557DERIVED

MeSH Terms

Conditions

Heart DiseasesHeart Failure

Interventions

Catheterization, Swan-Ganz

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac CatheterizationHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisCatheterization, PeripheralCatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

April 1, 2001

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

April 14, 2016

Record last verified: 2008-01