Ignite Creation Date:
2024-05-05 @ 9:05 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00806910
Status:
WITHDRAWN
Last Update Posted:
2011-06-23
First Post:
2008-12-10
Brief Title:
Diuretic and Renal Effects of Vaprisol When Administered Along With Furosemide and Nesiritide Continuous Infusion
Sponsor:
Albert Einstein Healthcare Network
Organization:
Albert Einstein Healthcare Network
Study Overview
Official Title:
Evaluation of the Diuretic and Renal Effects of Vaprisol When Administered Along With Furosemide and Nesiritide Continuous Infusion
Status:
WITHDRAWN
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor support withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Heart Failure is a growing and challenging public health concern in the United States Heart failure commonly manifests as a syndrome of salt and water retention Arginine vasopressin is a peptide hormone that is intimately involved in salt and water homeostasis AVP is released into the circulation in response low blood volume and hypernatraemia Despite fluid overload vasopressin levels are often inappropriately elevated in patients with heart failure and LV dysfunction Data suggest that vasopressin may also contribute to the deleterious circulatory response in patients with heart failure and play a role in the development and progression of the disease process In their study Udelson et al showed that vasopressin receptor antagonism with Conivaptan resulted in significant diuresis with stable hemodynamics in advanced heart failure patients Currently Intravenous diuretics and vasodilators are the standard of care in treating patients with acute decompensated heart failure We will be studying the renal and diuretic effects of add on therapy with intravenous Conivaptan in patients receiving intravenous Nesiritide and intravenous diuretics
Detailed Description:
Heart failure effects 5 to 6 million Americans and is increasing in prevalence There are about 550 000 new cases of heart failure every year and about 3 million admissions for acute decompensated heart failure every year The total cost of heat failure on the health systems is upwards of 35 billion dollars per year Despite advances in medical care the hospital readmission rate is 20 at one month and 50 at six months This prevailing situation mandates further exploration of novel therapeutic targets to treat this complex disease
Vasopressin levels are often elevated in patients with heart failure and LV dysfunction which is paradoxical and inappropriate It has been hypothesized that high levels of circulating vasopressin may play an important role not only in the pathophysiology of the heart failure syndrome but also contribute to its disease progression
Studies have shown that Conivaptan a Vasopressin antagonist results in favorable changes in hemodynamics and urine output without affecting blood pressure or heart rate No consensus has been reached for Conivaptan to be used as a sole agent in Acute Decompensated Heart Failure ADHF patients and IV loop diuretics andor vasodilators such as Nesiritide are used as the prime treatment for vascular congestion This prevailing situation brings the questions whether Conivaptan can be used as an adjunct to IV Furosemide andor Nesiritide presenting with ADHFWe intend to investigate this question in a cohort of heart failure patients with hyponatremia
This study will enroll 60 patients who meets all the inclusion criteria and none of the exclusion criteria admitted to the Albert Einstein Medical Center with the diagnosis of Acute Decompensated Heart Failure New York Heart Association class 3 and 4 The study population will be divided into 2 groups a treatment group and a placebo group as described below Each group will be comprised of 30 patients
The treatment group will be treated with Nesiritide infusion intravenous Furosemide either continuous infusion or bolus injection- total dose of Furosemide received at the end of the study will be calculated and IV Vaprisol The placebo group will be given Nesiritide infusion and intravenous Furosemideeither continuous infusion or bolus injection and placebo Treatment will be continued in both groups for 24-36 hours
Vasopressin levels are often elevated in patients with heart failure and LV dysfunction which is paradoxical and inappropriate It has been hypothesized that high levels of circulating vasopressin may play an important role not only in the pathophysiology of the heart failure syndrome but also contribute to its disease progression
Studies have shown that Conivaptan a Vasopressin antagonist results in favorable changes in hemodynamics and urine output without affecting blood pressure or heart rate No consensus has been reached for Conivaptan to be used as a sole agent in Acute Decompensated Heart Failure ADHF patients and IV loop diuretics andor vasodilators such as Nesiritide are used as the prime treatment for vascular congestion This prevailing situation brings the questions whether Conivaptan can be used as an adjunct to IV Furosemide andor Nesiritide presenting with ADHFWe intend to investigate this question in a cohort of heart failure patients with hyponatremia
This study will enroll 60 patients who meets all the inclusion criteria and none of the exclusion criteria admitted to the Albert Einstein Medical Center with the diagnosis of Acute Decompensated Heart Failure New York Heart Association class 3 and 4 The study population will be divided into 2 groups a treatment group and a placebo group as described below Each group will be comprised of 30 patients
The treatment group will be treated with Nesiritide infusion intravenous Furosemide either continuous infusion or bolus injection- total dose of Furosemide received at the end of the study will be calculated and IV Vaprisol The placebo group will be given Nesiritide infusion and intravenous Furosemideeither continuous infusion or bolus injection and placebo Treatment will be continued in both groups for 24-36 hours
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