Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00021957 |
| Other study ID # |
978 |
| Secondary ID |
R01HL067691 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
August 10, 2001 |
| Last updated |
February 17, 2016 |
| Start date |
April 2001 |
| Est. completion date |
March 2005 |
Study information
| Verified date |
May 2005 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To determine the value of serum markers as surrogate endpoints and hemodynamic biomarkers of
congestive heart failure.
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.
