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Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE)

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ClinicalTrials.gov Identifier: NCT00000619
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : April 14, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

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.

Condition or disease Intervention/treatment Phase
Heart Diseases Heart Failure, Congestive Heart Failure Procedure: catheterization, Swan-Ganz Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : April 2001
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure





Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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.

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: ESCAPE
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000619     History of Changes
Other Study ID Numbers: 122
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: January 2008

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases