Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505791
Status:
WITHDRAWN
Last Update Posted:
2015-11-11
First Post:
2007-07-19
Brief Title:
Double Blind Randomized Placebo Controlled Trial of Natrecor in Acute Decompensated Heart Failure With Normal EF
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Double Blind Randomized Placebo Controlled Trial of Natrecor in Patients Hospitalized for Decompensated Heart Failure in the Presence of a Normal Left Ventricular Ejection Fraction
Status:
WITHDRAWN
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to enroll patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Heart failure HF is a disease that is caused by a reduced heart muscle function Reduced heart muscle function can occur as a consequence of reduced pumping activity from a weak heart muscle or because of a stiff heart muscle This study is looking at the effectiveness of Natrecor nesiritide in patients that require hospitalization due to worsening heart failure as a result of a stiff or thickened heart muscle Natrecor is a man-made version of a protein that my body makes on its own and has been approved for the treatment of patients requiring hospital admission for heart failure and have shortness of breath at rest or with minimal activity
Natrecor has shown to lower the pressures in the heart and decreases the congestion in the lungs This study is being done to see if the addition of a Natrecor to standard medical therapy for HF will improve symptoms faster or more completely than giving only the standard treatment for CHF
Natrecor has shown to lower the pressures in the heart and decreases the congestion in the lungs This study is being done to see if the addition of a Natrecor to standard medical therapy for HF will improve symptoms faster or more completely than giving only the standard treatment for CHF
Detailed Description:
Despite an increasing number of patients hospitalized with decompensated heart failure in the presence of a normal ejection fraction there is little clinical trial data to guide clinicians in their acute management Since the number of patients hospitalized with decompensated heart failure in the presence of normal ejection fraction 50 is increasing it is imperative to develop effective therapies which are supported by clinical evidence such as randomized clinical trials The purpose of this study is to evaluate the utility of natriuretic peptide for the specific management of these patients
Loop diuretics such as Furosemide are powerful diuretic agents which are used as a first-line therapy in volume overloaded patients with low ejection fraction heart failure Despite their widespread use they can cause severe electrolyte and volume abnormalities contributing to increased morbidity and mortality These adverse effects are exacerbated even further in heart failure patients with normal ejection fraction since these patients are usually older have worse renal function and are more susceptible to volume depletion and its effects The FDA approved Natrecor for Acute Decompensated Heart Failure and did not differ between low ejection fraction and normal ejection fraction heart failure Given however the low number of patients with normal ejection fraction heart failure in clinical trials and the paucity of outcome data in these patients we propose to specifically study them
Brief Description of Experimental Approach
Patients who present to the emergency room diagnosed with acute decompensated heart failure requiring the administration of intravenous diuretics and found to have normal contractile function will be eligible for participation in this study Patients must have pulmonary congestion documented on their admitting chest X-ray and clinical evidence of volume overload such as rales or edema on physical examination at the time of randomization Patients will have received at least one dose of IV Furosemide either in-route to the emergency room or on presentation to the emergency room An echocardiogram will be obtained after presentation to the emergency room documenting a normal 50 left ventricular ejection fraction Patients will be randomized to Natrecor or placebo in addition to a standard medical therapy Study drug will be administered for 24 hours Study drug will be initiated with a 2-µgkg loading bolus followed by 01-µgkgmin infusion This may be increased at a rate of 005-µgkgmin every 3 hours until maximum dose of 03-µgkgmin Any increase in the infusion rate will be preceded by a 1-µgkg bolus and increases in infusion rates will be permitted only in patients who have a systolic blood pressure 100 mmHg IV Nitroglycerin and IV Milrinone will be prohibited within 2 hours prior to initiating study drug infusion to three hours after completion of study drug infusion All other intravenous vasoactive medications including other IV inotropes will be avoided within 2 hours prior to initiating study drug infusion to three hours after start of study drug infusion Oral ACE inhibitors will be avoided from 2 hours prior to initiating study drug infusion to 30 minutes after start of study drug so as to avoid potential hypotension Concomitant standard of care medications including diuretics IV or PO ACE inhibitors Aldactone Digoxin etc will be left to investigator discretion to be administered during the hospital stay as indicated The primary endpoint of this study will be an absolute reduction in brain natriuretic peptide BNP levels three hours after discontinuation of the study drug BNP is elevated in acute decompensated heart failure and has utility in outcome severity and prognosis of patients with ADHF
Secondary endpoints will include all cause in-hospital mortality physician and patient global score at 24 hours twenty-four hour urine output after start of study drug infusion weight change at 24 hours after start of study drug infusion number of patients with K 35meq at 24 hours change in creatinine at 24 hours after start of study drug and at discharge or at 3 days BNP levels at baseline 3 hours after discontinuation of the study drug and at discharge or at 3 days total diuretic dose of IV and PO Lasix at 48 hours and 72 hours after randomization or at discharge changes in diastolic indices measured by transthoracic echocardiography 24 hours after the start of the study drug and 30 day post-randomization all cause mortality
Loop diuretics such as Furosemide are powerful diuretic agents which are used as a first-line therapy in volume overloaded patients with low ejection fraction heart failure Despite their widespread use they can cause severe electrolyte and volume abnormalities contributing to increased morbidity and mortality These adverse effects are exacerbated even further in heart failure patients with normal ejection fraction since these patients are usually older have worse renal function and are more susceptible to volume depletion and its effects The FDA approved Natrecor for Acute Decompensated Heart Failure and did not differ between low ejection fraction and normal ejection fraction heart failure Given however the low number of patients with normal ejection fraction heart failure in clinical trials and the paucity of outcome data in these patients we propose to specifically study them
Brief Description of Experimental Approach
Patients who present to the emergency room diagnosed with acute decompensated heart failure requiring the administration of intravenous diuretics and found to have normal contractile function will be eligible for participation in this study Patients must have pulmonary congestion documented on their admitting chest X-ray and clinical evidence of volume overload such as rales or edema on physical examination at the time of randomization Patients will have received at least one dose of IV Furosemide either in-route to the emergency room or on presentation to the emergency room An echocardiogram will be obtained after presentation to the emergency room documenting a normal 50 left ventricular ejection fraction Patients will be randomized to Natrecor or placebo in addition to a standard medical therapy Study drug will be administered for 24 hours Study drug will be initiated with a 2-µgkg loading bolus followed by 01-µgkgmin infusion This may be increased at a rate of 005-µgkgmin every 3 hours until maximum dose of 03-µgkgmin Any increase in the infusion rate will be preceded by a 1-µgkg bolus and increases in infusion rates will be permitted only in patients who have a systolic blood pressure 100 mmHg IV Nitroglycerin and IV Milrinone will be prohibited within 2 hours prior to initiating study drug infusion to three hours after completion of study drug infusion All other intravenous vasoactive medications including other IV inotropes will be avoided within 2 hours prior to initiating study drug infusion to three hours after start of study drug infusion Oral ACE inhibitors will be avoided from 2 hours prior to initiating study drug infusion to 30 minutes after start of study drug so as to avoid potential hypotension Concomitant standard of care medications including diuretics IV or PO ACE inhibitors Aldactone Digoxin etc will be left to investigator discretion to be administered during the hospital stay as indicated The primary endpoint of this study will be an absolute reduction in brain natriuretic peptide BNP levels three hours after discontinuation of the study drug BNP is elevated in acute decompensated heart failure and has utility in outcome severity and prognosis of patients with ADHF
Secondary endpoints will include all cause in-hospital mortality physician and patient global score at 24 hours twenty-four hour urine output after start of study drug infusion weight change at 24 hours after start of study drug infusion number of patients with K 35meq at 24 hours change in creatinine at 24 hours after start of study drug and at discharge or at 3 days BNP levels at baseline 3 hours after discontinuation of the study drug and at discharge or at 3 days total diuretic dose of IV and PO Lasix at 48 hours and 72 hours after randomization or at discharge changes in diastolic indices measured by transthoracic echocardiography 24 hours after the start of the study drug and 30 day post-randomization all cause mortality
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 |
|---|---|---|---|
| IRB 0120050150 | OTHER_GRANT | UMDNJ 106199 | None |