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

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000619
First received: October 27, 1999
Last updated: January 15, 2008
Last verified: January 2008
History of Changes
  Purpose

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 Intervention Phase
Heart Diseases
Heart Failure, Congestive
Heart Failure
 Procedure: catheterization, Swan-Ganz
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 2001
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

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

ClinicalTrials.gov Identifier: NCT00000619     History of Changes
Other Study ID Numbers: 122
Study First Received: October 27, 1999
Last Updated: January 15, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Heart Diseases
Heart Failure
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013