THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluatio

Conditions: Hyponatremia
MedDRA version: 9.1Level: LLTClassification code 10021038Term: Hyponatremia

Registration Number: EUCTR2006-002567-62-CZ

Lead Sponsor: Cardiokine Biopharma, LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 650

Inclusion Criteria

1. Men and Women with age greater than or equal to 18 years.
2. Baseline Serum sodium concentration < 135 mEq/L. Repeat measures of serum sodium are alllowed; the last serum sodium result within 24 hours prior to randomization will serve as the qualifying measurement.
3. Current hospitalization for worsening of chronic congestive heart failure.
a) Chronic heart failure is defined as requiring treatment for a minimum of 30-Days prior to hospitalization. Study patients are expected to be on standard background therapy for Congestive Heart Failure.
4. The patient has clinical evidence of volume overload with at least two of the following:
a) dyspnea,
b) pulmonary congestion (rales),
c) peripheral edema,
d) increased jugular venous pressure and/or hepatic congestion with ascites,
e) chest x-ray consistent with CHF, or
f) plasma BNP = 150 pg/mL or NT pro-BNP = 450 pg/mL.
5. The patient has documented Left Ventricular Ejection Fraction (LVEF) within the past year.
6. Supine systolic arterial blood pressure = 90 mmHg.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Previous participation in this or any other lixivaptan clinical trial.
2. Participation in any other investigational study of drugs or devices within 30-Days prior to Screening.
3. Women who will not adhere to the reproductive precautions as outlined in section 4.3 of the protocol and in the informed consent form.
4. Positive urine pregnancy test.
5. Inability to provide informed consent.
6. Inability to respond to thirst.
7. Inability to take oral medications.
8. Acute severe hyponatremia.
9. Overt symptoms of hyponatremia requiring immediate medical intervention (e.g., severe lethargy, coma, seizures).
10. Hemodynamically significant uncorrected primary cardiac valvular disease.
11. Hypertrophic cardiomyopathy (obstructive or non-obstructive).
12. CHF due to uncorrected thyroid disease (i.e., T4 above or below the limits of the reference range), active myocarditis or known amyloid cardiomyopathy.
13. History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator.
14. ST-segment elevation myocardial infarction (STEMI) within 30-Days or active myocardial ischemia at the time of enrollment.
15. History of stroke within 30-Days prior to screening.
16. History of a cardiac revascularization procedure within 30-Days prior to screening.
17. Subjects who are on cardiac mechanical support.
18. History of bi-ventricular pacer placement within the last 30-Days.
19. Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, ultrafiltration or dialysis, or other cardiac surgery within 30 days following study enrollment.
20. Serum creatinine > 3.0 mg/dL/265.2 mol/L.
21. Uncontrolled diabetes mellitus as defined by the Investigator (e.g. HbA1c > 9%).
22. Adrenal insufficiency, whether treated or not. If serum cortisol is less than the lower limit of the reference range, the patient is excluded and should be referred for follow-up evaluation.
23. History of primary significant liver disease or acute hepatic failure, as defined by the Investigator.
24. History of chronic drug/medication abuse within the 6 months, or current alcohol abuse.
25. Co-morbid condition with an expected survival less than six months.

Specific requirements for females
Women of child-bearing potential must demonstrate a negative urine pregnancy test prior to randomization and at the final study visit 30 days after the last dose of study drug. In addition, women of child-bearing potential must agree to use one of the methods of birth control detailed in 4.3 of the protocol for the entire study period including screening, the titration and treatment phases and the 30-day follow-up period.