Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021957
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2001-08-10
Brief Title:
ESCAPE Mechanistic Substudies - Ancillary to ESCAPE
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the value of serum markers as surrogate endpoints and hemodynamic biomarkers of congestive heart failure
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL067691 | NIH | None | httpsreporternihgovquickSearchR01HL067691 |