Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145873
Status:
TERMINATED
Last Update Posted:
2013-10-08
First Post:
2005-09-01
Brief Title:
Nesiritide in Chronic Heart Failure
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Continuous Infusion Nesiritide in Chronic Heart Failure-University of Chicago CINCH-UC
Status:
TERMINATED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to complete study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to look at the safety and effectiveness of longer term intravenous IV infusion of the study drug nesiritide in patients with acutely decompensated chronic heart failure Nesiritide Natrecor is a man-made version of a human hormone that dilates veins and arteries Nesiritide Natrecor is currently FDA-approved for short-term inpatient IV treatment of acutely decompensated chronic heart failure
Hypothesis Nesiritide administered by continuous intravenous infusion in the outpatient setting is a safe treatment for refractory Class III IV chronic heart failure due to systolic or diastolic dysfunction regardless of renal function when administered over a 12-week period
Corollary 1 Nesiritide when infused continuously over 12 weeks will improve the overall condition of patients with chronic heart failure These mechanisms include reducing hospitalizations when compared with the previous six months improving symptoms as measured by the Minnesota Living with Heart Failure short questionnaire and improving functional capacity as measured by 6-minute walk testing
Corollary 2 Nesiritide infusion will be associated with a statistically significant decrease in N-terminal pro-BNP levels and cyclic GMP levels compared with patients receiving placebo infusions
Hypothesis Nesiritide administered by continuous intravenous infusion in the outpatient setting is a safe treatment for refractory Class III IV chronic heart failure due to systolic or diastolic dysfunction regardless of renal function when administered over a 12-week period
Corollary 1 Nesiritide when infused continuously over 12 weeks will improve the overall condition of patients with chronic heart failure These mechanisms include reducing hospitalizations when compared with the previous six months improving symptoms as measured by the Minnesota Living with Heart Failure short questionnaire and improving functional capacity as measured by 6-minute walk testing
Corollary 2 Nesiritide infusion will be associated with a statistically significant decrease in N-terminal pro-BNP levels and cyclic GMP levels compared with patients receiving placebo infusions
Detailed Description:
This is a single center double-blinded crossover placebo-controlled pilot study to evaluate the effects of nesiritide in patients with chronic heart failure This study will only take place at the University of Chicago Hospitals It is double-blinded which means that the neither subject nor their study doctor will know which study drug the subject will receive However in an emergency this information can be obtained quickly The study is placebo-controlled which means subjects will not receive study drug at some point during the study however because it is a cross-over study subjects will be receiving nesiritide at some point in the study Subjects will receive the study drug nesiritide for six out of the 12 weeks of the study-either the first six weeks or the last six weeks
The procedures for the study consist of informed consent questions about the subjects heart failure blood sample assessment of heart failure severity based on symptoms six minute walk test and the Minnesota Living with Heart Failure Questionnaire history of heart failure symptoms and emergency room visits diuretic and baseline medication history long term IV for medication infusions adjustment of study drug and regularly taken medications 6 weeks of receiving long term IV infusion of drug blood taken for lab tests at each clinic visit and an informational card provided for subjects to use for on-call physicians
Up to ten consecutive patients who decline participation in the study will be asked to participate in a registry to follow their course over the study interval Baseline data obtained from medical records will be recorded as will the number of hospitalizationsER visits and NYHA class during the study period These subjects will be surveyed by telephone monthly for the duration of the study
The procedures for the study consist of informed consent questions about the subjects heart failure blood sample assessment of heart failure severity based on symptoms six minute walk test and the Minnesota Living with Heart Failure Questionnaire history of heart failure symptoms and emergency room visits diuretic and baseline medication history long term IV for medication infusions adjustment of study drug and regularly taken medications 6 weeks of receiving long term IV infusion of drug blood taken for lab tests at each clinic visit and an informational card provided for subjects to use for on-call physicians
Up to ten consecutive patients who decline participation in the study will be asked to participate in a registry to follow their course over the study interval Baseline data obtained from medical records will be recorded as will the number of hospitalizationsER visits and NYHA class during the study period These subjects will be surveyed by telephone monthly for the duration of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1 | None | None | None |