ESCAPE Mechanistic Substudies - Ancillary to ESCAPE

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00021957
First received: August 10, 2001
Last updated: June 23, 2005
Last verified: May 2005

August 10, 2001
June 23, 2005
April 2001
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00021957 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
ESCAPE Mechanistic Substudies - Ancillary to ESCAPE
Not Provided

To determine the value of serum markers as surrogate endpoints and hemodynamic biomarkers of congestive heart failure.

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.

Observational
Time Perspective: Longitudinal
Not Provided
Not Provided
Not Provided
Not Provided
  • Cardiovascular Diseases
  • Heart Diseases
  • Heart Failure
  • Heart Failure, Congestive
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
March 2005
Not Provided

No eligibility criteria

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00021957
978
Not Provided
Not Provided
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Investigator: Robert Califf Duke University
National Heart, Lung, and Blood Institute (NHLBI)
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP