CTRI/2009/091/000319进行中（未招募）3 期
The BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardioc Patient EvaluationAcronym: BALANCE
Cardiokine Biopharma0 个研究点目标入组 650 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 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
入排标准
入选标准
- •1. Men and Women with age greater than or equal to 18 years.
- •2. Baseline serum sodium comcentration less than 135mEq/L.
- •3. Current hospitalization for worsening of chronic CHF.
- •4. The patient has clinical evidence of volume overload.
- •5. The patient has a documented left ventricular ejection fraction (LVEF) within the past year.
- •6. Supine systolic arterial blood pressure greater than or equal to 90mmHg.
排除标准
- •1. Previous participation in this or any other Lixivaptan clinical trial.
- •2. Participation in any other investigational study within 30 days prior to screening.
- •3. Women who will not adhere to the reproductive precautions as outlined in the protocol and in the informed consent.
- •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.
- •10. Hemodynamically significant uncorrected primary cardiac valvular disease.
- •11. Hypertrophic cardiomyopathy.
- •12. CHF due to uncorrected thyroid disease, 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 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 cardiac revascularization procedure within 30 days prior to screening.
- •17. Patients who are on cardiac mechanical support.
- •18. History of bi-ventricular pacer placement within the last 30 days.
- •19. Planned revascularization procedures, electrophysiologic device implantation, cardiac support implantation, ultrafiltration or dialysis, or other cardiac surgery within 30 days following study enrollment.
- •20. Serum creatinine greater than 3.0 mg/dL/265.2mol/L.
- •21. Uncontrolled diabetes mellitus as defined by the investigator (eg. HbA1c > 9%).
- •22. Adrenal insufficiency, whether treated or not.
- •23. History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
- •24. History of chronic drug/medication abuse within 6 months; or current alcohol abuse.
- •25. Co-morbid condition with an expected survival of less than 6 months.
研究者
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