EUCTR2006-002567-62-ES进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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