ESCAPE Mechanistic Substudies - Ancillary to ESCAPE

February 17, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To determine the value of serum markers as surrogate endpoints and hemodynamic biomarkers of congestive heart failure.

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND:

The study will develop easily obtained surrogate markers to be incorporated into a model that can function in place of "hard" end-points in the assessment of new treatments in patients with heart failure. In view of the epidemiologic importance of heart failure and the large and expensive studies currently required to test new treatments, a successful surrogate marker model would be a major advance in this field that would both speed the development and reduce the cost of therapeutic advances.

The study is ancillary to the NHLBI-supported clinical trial "Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE)." ESCAPE compares 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 of ESCAPE is to determine costs and resource utilization of PAC-directed treatment strategy compared to non-invasive treatment strategy.

The study is in response to an initiative "Ancillary Studies in Heart, Lung, and Blood Disease Trials" released by the National Heart, Lung, and Blood Institute in June 2000.

DESIGN NARRATIVE:

The ancillary, prospective, observational study is designed to evaluate the potential of the serum biomarkers atrial natriuretic peptide, brain natriuretic peptide, and cardiac troponins to serve both as prognostic indices and as surrogate endpoints for death and hospitalization in heart failure trials. The first goal wlll be accomplished by evaluating outcomes. The investigators will develop a risk score for patients with advanced heart failure that incorporates the serum biomarkers and clinical variables and test for interactions between this score and pulmonary artery catheterization. They will evaluate the ability of serum biomarkers to serve as objective measures of both clinical and hemodynamic status and will assess the potential of these markers to serve as tools to assist with the selection and titration of therapies. In addition. they will examine the relations between levels of natriuretic peptides, troponins, and catecholamines.

This information will be the launching point for the second goal, which will be to examine the relationship between the serum biomarkers and the treatment effect of pulmonary-artery catheterization on death and hospitalization. In addition, the investigators will evaluate the relations between levels of natriuretic peptides, troponins, and the treatment effects of B-adrenergic antagonists and inotropic agents on clinical outcomes. Ultimately, they intend to construct a statistical model that incorporates the serum biomarkers with greatest promise and clinical variables demonstrated to predict survival. This final model may prove to be the best surrogate endpoint possible, as it will capture an array of physiological mechanisms through which pulmonary-artery catheter guided therapy may have an effect.

This proposed substudy will be conducted within the framework of the ESCAPE trial. Natriuretic peptide levels are currently being collected at randomization, discharge, one month, and six months as a secondary endpoint of the trial. Catecholamines are also being collected at baseline and three months. In addition, the ESCAPE investigators are all ready capturing detailed demographic, clinical, and physiological information as part of the protocol for the primary study.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Robert Califf, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

August 10, 2001

First Submitted That Met QC Criteria

August 9, 2001

First Posted (Estimate)

August 10, 2001

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

May 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 978 (Other Identifier: University of California, Irvine)
  • R01HL067691 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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