Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT02183792
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02183792
Study Brief:
Protocol Section:
NCT02183792