Status:
COMPLETED
Aquaresis Utility for Hyponatremic Acute Heart Failure Study
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Otsuka America Pharmaceutical
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Hyponatremia is a common finding in acute heart failure (HF) patients and is associated with worse prognosis. In addition to its prognostic value, hyponatremia may have importance during the acute man...
Eligibility Criteria
Inclusion
- Acute HF with signs or symptoms of volume overload \[i.e. elevated jugular venous pulsation (JVP), rales, edema\]
- Serum sodium \< 135 mEq/L at time of or within first 48 hours of hospitalization
- Randomized within 48 hours of presentation to hospital
- ≥ 18 years of age
- Informed consent
Exclusion
- Severe symptomatic hyponatremia requiring acute treatment
- Severe renal impairment upon admission (creatinine clearance \< 20 mL/min)
- Renal replacement therapy dependent, or requiring upon admission
- Acute coronary syndrome on admission
- Requires or has a mechanical circulatory support device
- Evidence of cardiogenic shock requiring intravenous vasopressors
- Pregnancy
- Patient requiring concomitant use of strong CYP3A4 inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02183792
Start Date
December 1 2014
End Date
March 1 2018
Last Update
May 28 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Keck Medical Center of USC
Los Angeles, California, United States, 90033
2
LAC+USC Medical Center
Los Angeles, California, United States, 90033