THE BALANCE study: Treatment of Hyponatremia based on Lixivaptan in NYHA class III/IV Cardiac Patient Evaluation

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 650

Inclusion Criteria

1. The subject, or the subject?s legally authorized representative, has provided written informed consent prior to initiation of any study-related procedures. 2. Male or female subject; females must be postmenopausal (at least 12 months since last menstrual period); surgically sterile (hysterectomy or tubal ligation at least 6 months prior to enrollment); using an intrauterine device; or a double barrier (e.g., diaphragm plus spermicide) non-hormonal contraceptive therapy for 2 weeks prior to Screening and agree to continue non-hormonal contraceptive therapy and must have a negative serum pregnancy test at the Screening visit. Abstinence is also an acceptable method of birth control. 3. The subject is 18 years of age or older. 4. The subject has either ischemic or non-ischemic cardiomyopathy (left ventricular dilatation and reduced systolic function) with a history of symptoms of New York Heart Association (NYHA) Class III or IV chronic heart failure (HF) (Appendix III). 5. The subject is currently hospitalized (from the time of screening) and has been hospitalized for no more than 3 days (72 hours). 6. The subject has at least a 3 month history of HF. The clinical diagnosis of HF must have been made at least 3 months prior to enrollment. A subject must have been hospitalized for HF within the previous 12 months.
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. The subject was previously randomized to this study protocol. 2. If female, the subject is pregnant, breast feeding or using hormonal contraceptive therapy (injectable or topical contraceptives within 90 days of Screening or subcutaneous contraceptives within one year of Screening); or the subject is using oral hormonal contraceptive therapy during the 2 weeks prior to the Screening Visit. 3. The subject is unable to take oral medications. 4. The subject has severe hyponatremia (serum sodium < 120 mEq/L) or symptomatic hyponatremia (e.g., severe lethargy, coma, seizures, mental status changes attributable to hyponatremia). 5. The subject has uncontrolled diabetes mellitus (glucose ≥220 mg/dL). 6. The subject has acute pulmonary edema and is currently receiving any of the following: nitroprusside, nesiritide, intravenous nitroglycerine, IV inotrope or invasive hemodynamic monitoring with a pulmonary artery catheter

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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