THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient EvaluationEstudio BALANCE: Tratamiento de la Hyponatremia mediante lixivaptan en la evaluación del paciente con insuficiencia cardiaca con Clase III/IV de la NYHA

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

Registration Number: EUCTR2006-002567-62-ES

Lead Sponsor: Cardiokine Biopharma, LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 650

Inclusion Criteria

1. Men and Women with age greater than or equal to 18 years.
2. Current hospitalization for chronic congestive heart failure with admission up to 48 hours prior to randomization. Chronic heart failure is defined as requiring treatment for a minimum of 30 days prior to hospitalization.
3. NYHA Class III or IV at the time of hospitalization (appendix II).
4. The subject has clinical evidence of volume overload with at least two of the following: dyspnea, pulmonary congestion, peripheral edema, increased jugular venous pressure and/or hepatic congestion with ascites.
5. LVEF < 40% within the past year.
6. Baseline Serum sodium concentration =120 mEq/L to < 135 mEq/L.
Also, female subjects are eligible to participate in this study if they are not pregnant or lactating, and are at least one of the following:
• Surgically sterile (via hysterectomy or bilateral tubal ligation =6 months prior to enrollment).
• Post-menopausal (last menstrual period =12 months prior to enrollment).
• For women of child-bearing potential:
o Use of an intrauterine device; or use of a double barrier method of pregnancy prevention (e.g., diaphragm plus spermicide) for 2 weeks prior to screening and during the Screening Period, or
o Use of oral, injectable, topical or subcutaneous hormonal contraceptives for 2 weeks prior to screening and during the Screening Period, and
o Agrees to continue the same contraceptive method for the duration of the Treatment Period and for 30 days from the last dose of lixivaptan administration, and
o Demonstrates a negative urine pregnancy test result prior to the first lixivaptan administration.
o Abstinence is an acceptable means of birth control.
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 the informed consent form.
4. Positive urine pregnancy test.
5. Inability to provide informed consent.
6. Inability to take oral medications.
7. Symptomatic hyponatremia (e.g., severe lethargy, coma, seizures, mental status changes attributable to hyponatremia).
8. Uncontrolled diabetes mellitus (glucose =220 mg/dL).
9. Hemodynamically significant uncorrected primary cardiac valvular disease.
10. Hypertrophic cardiomyopathy (obstructive or non-obstructive).
11. CHF due to uncorrected thyroid disease (i.e., T4 above or below the limits of the reference range), active myocarditis or known amyloid cardiomyopathy.
12. History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator.
13. History of myocardial infarction, unstable angina or evidence of active ischemia within 30 days prior to screening.
14. History of stroke within 30 days prior to screening.
15. History of a cardiac revascularization procedure within 30 days prior to screening.
16. Subjects who are on cardiac mechanical support.
17. History of bi-ventricular pacer placement within the last 30 days.
18. Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, ultrafiltration or dialysis, cardiac transplantation, or other cardiac surgery within 30 days following study enrollment.
19. Supine systolic arterial blood pressure < 90 mmHg.
20. Serum creatinine > 3.0 mg/dL
21. History of primary significant liver disease or acute hepatic failure, as defined by the Investigator.
22. History of drug or medication abuse within the past year, or current alcohol abuse.
23. Co-morbid condition with an expected survival less than six months.
24. Adrenal insufficiency, whether treated or not. If serum cortisol is less than the lower limit of the reference range, the subject is excluded and should be referred for a follow-up evaluation.