Age
Item
1. men and women with age greater than or equal to 18 years.
boolean
C0001779 (UMLS CUI [1])
Study Subject Participation Status | Lixivaptan | Hyponatremia Treatment required for | Heart failure
Item
2. prior successful participation in a randomized, blinded, placebo-controlled phase 3 lixivaptan study of hyponatremia in heart failure (protocol ck-lx3401) with evidence of continued need for therapy as follows:
boolean
C2348568 (UMLS CUI [1])
C0676838 (UMLS CUI [2])
C0020625 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C0018801 (UMLS CUI [4])
Treatment completed | Placebo | Lixivaptan
Item
patient completed full course of treatment (e.g., either placebo or lixivaptan). treatment assignments for protocol ck-lx3401 will not be unblinded prior to participation in the extension study.
boolean
C0580352 (UMLS CUI [1])
C0032042 (UMLS CUI [2])
C0676838 (UMLS CUI [3])
Serum sodium measurement post treatment | Clinical Study Follow-up | Lixivaptan | Hyponatremia
Item
baseline serum sodium concentration < 135 meq/l following a 30 day post treatment follow-up period in a lixivaptan hyponatremia parent trial. repeat measures of serum sodium are allowed; the last serum sodium result within 24 hours prior to randomization will serve as the qualifying measurement.
boolean
C0523891 (UMLS CUI [1,1])
C2709088 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2])
C0676838 (UMLS CUI [3])
C0020625 (UMLS CUI [4])
Fluid overload
Item
3. the patient has clinical evidence of volume overload with at least one of the following:
boolean
C0546817 (UMLS CUI [1])
Dyspnea
Item
dyspnea
boolean
C0013404 (UMLS CUI [1])
Pulmonary congestion | Rales
Item
pulmonary congestion (rales)
boolean
C0242073 (UMLS CUI [1])
C0034642 (UMLS CUI [2])
Peripheral edema
Item
peripheral edema
boolean
C0085649 (UMLS CUI [1])
Raised jugular venous pressure | Hepatic congestion | Ascites
Item
increased jugular venous pressure and/or hepatic congestion with ascites
boolean
C0520861 (UMLS CUI [1])
C0267821 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
Chest X-ray Consistent with Congestive heart failure
Item
chest x-ray consistent with chf; or
boolean
C0039985 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0018802 (UMLS CUI [1,3])
BNP in serum or plasma | NT-proBNP
Item
plasma bnp ≥150 pg/ml or nt pro-bnp ≥ 450 pg/ml
boolean
C4066092 (UMLS CUI [1])
C0754710 (UMLS CUI [2])
Pregnancy | Pregnancy test positive | Breast Feeding | Contraceptive methods Unwilling
Item
1. women who are pregnant (positive pregnancy test), breastfeeding or who will not adhere to the reproductive precautions as outlined in this protocol and in the informed consent form.
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Informed Consent Unable
Item
2. inability to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Hyponatremia Severe | Symptoms Hyponatremia | Patient need for Intervention Immediate | Coma | Seizures
Item
3. acute severe hyponatremia with overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).
boolean
C0020625 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0020625 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C0205253 (UMLS CUI [3,3])
C0009421 (UMLS CUI [4])
C0036572 (UMLS CUI [5])
Hyponatremia | Hyponatremia Transient | Hyponatremia Associated with Craniocerebral Trauma | Hyponatremia Postoperative state
Item
4. acute or transient hyponatremia (e.g., associated with head trauma or postoperative state).
boolean
C0020625 (UMLS CUI [1])
C0020625 (UMLS CUI [2,1])
C0205374 (UMLS CUI [2,2])
C0020625 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0018674 (UMLS CUI [3,3])
C0020625 (UMLS CUI [4,1])
C0231287 (UMLS CUI [4,2])
HYPONATREMIA HYPOVOLEMIC
Item
5. hyponatremia in hypovolemic states. hypovolemia is defined as the presence of clinical evidence of fluid volume depletion.
boolean
C0745165 (UMLS CUI [1])
HYPONATREMIA EUVOLEMIC | Inappropriate ADH Syndrome
Item
6. euvolemic hyponatremia (e.g., siadh, etc.). euvolemic hyponatremia is defined as low serum sodium in the presence of normal total body sodium due to mild to moderate increases in total body water without edema.
boolean
C0745159 (UMLS CUI [1])
C0021141 (UMLS CUI [2])