Status:
WITHDRAWN
Diuretic and Renal Effects of Vaprisol When Administered Along With Furosemide and Nesiritide Continuous Infusion
Lead Sponsor:
Albert Einstein Healthcare Network
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 hor...
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 he...
Eligibility Criteria
Inclusion
- Patients over the age of 18 and able to consent
- LVEF ≤40% (as measured within last 6 months before entering into the study)
- Patients with Acute Decompensated Heart Failure (ADHF) (NYHA class 3 \& 4)
- Patients with estimated GFR \>40ml/min as calculated by Cockcroft-Gault or MDRD formula
- Serum Sodium level \<135 meq/L
- Ability to understand and willing to sign informed consent
- Willingness to follow-up in the clinic as outpatient
Exclusion
- Patients with Acute Coronary Syndrome (ACS: Unstable angina, NSTEMI or STEMI)
- Patients on pressors (including Vasopressin analogs) for hemodynamic stability
- Supine systolic blood pressure \<100 mm Hg
- Hypersensitivity to Conivaptan
- Concomitant use of medications that affects hepatic drug metabolism (e.g. Ketoconazole, Itraconazole, Ritonavir, Indinavir, Clarithromycin etc.)
- Significant liver dysfunction (ALT \& AST more than twice the upper limit of normal)
- Uncontrolled bradyarrhythmias or tachyarrhythmias
- Pacemaker or defibrillator implantation or other cardiac surgery \<60 days
- Severe obstructive pulmonary disease
- Significant uncorrected valvular or congenital heart disease
- Obstructive cardiomyopathy
- Significant renal impairment (defined as a serum creatinine \>2.5 mg/dL or creatinine clearance \<40 ml/min).
- Radiocontrast infusion within \<7 days
- Pregnant or lactating female subject
- Untreated severe hyperthyroidism, hypothyroidism or adrenal insufficiency
- Expected requirement for emergent treatment of hypernatremia during the course of the study
- Known urinary outflow obstruction, unless subject is, or can be catheterized during the study
- Serum albumin \< 1.5 gm/dl documented any time during any time during seven days prior to study drug administration
- Any concurrent illness, which in opinion of the investigator, may interfere with treatment or evaluation of safety.
- White blood cell count (WBC) count \< 3000 /mL documented any time during seven days prior to study drug administration or anticipated drop in WBC count \<3000/mL during the period of study due to chemotherapy.
- Participation in another clinical trial of an investigational drug (including placebo) or device within 30 days of screening for entry into the present study
- Subject has moderate ascites on physical examination secondary to hepatic dysfunction (ascites primarily related to cardiac dysfunction will be allowed as long as subject does not have cardiac cirrhosis).
- Subject has moderate to severe hepatic impairment as evidenced by Child-Pugh B or C criteria.
- Subject has a history of hepatic encephalopathy, hematemesis or melena.
- Subjects with altered mental status due to severe hyponatremia.
- Patient belonging to a vulnerable population such as institutionalized person, prisoners and persons with decisional incapacity or dementia.
- Patients on medications which are known to cause drug interactions such as Nicardipine, lovastatin, Ritonovir, Doxorubicin Etc
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00806910
Start Date
October 1 2008
End Date
February 1 2010
Last Update
June 23 2011
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