EUCTR2006-001637-18-SE进行中（未招募）不适用
A multicentre, randomised, double-blind, placebo-controlled study of the effects of KW-3902 Injectable Emulsion on heart failure signs and symptoms and renal function in subjects with acute heart failure syndrome and renal impairment who are hospitalised for volume overload and require intravenous diuretic therapy. - PROTECT {CKI-302}
ovaCardia Inc (wholly owned subsidiary of Merck & Co. Inc)0 个研究点目标入组 1,000 人开始时间: 2006年6月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
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. Able to provide written informed consent or a legally authorized representative is able to provide written informed consent
- •2. Male or female 18 years of age or greater
- •3. History of heart failure of at least 14 days duration for which diuretic therapy has been prescribed
- •4. Hospitalized for AHFS requiring IV diuretic therapy. AHFS is defined as dyspnea at rest or with minimal exertion and signs of fluid overload manifested by at least one of the following at time of randomization:
- •JVP >8 cm, or
- •Pulmonary rales =1/3 up the lung fields, not clearing with cough, or
- •=2+ peripheral edema, or pre-sacral edema
- •5. Eligible for randomization within 24-hours of presentation to the hospital (including time spent in the emergency department.
- •Study drug infusion should start as soon as possible following randomization, preferably in the morning hours.
- •6. Anticipated need for IV furosemide =40 mg/day (or equivalent dose of IV loop diuretic) for at least 24 hours after start of study drug
- •7. Impaired renal function defined as a creatinine clearance on admission between 20-80 mL/min using the Cockcroft-Gault equation for estimating creatinine clearance (corrected for height in edematous or obese subjects =100 kg)
- •8. Systolic blood pressure =95 mmHg (subjects with a systolic blood pressure of 90 –94 mmHg at randomization may be included if their usual systolic blood pressure measurements are consistently within this range while clinically stable)
- •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
- •9. Pregnant or breast feeding women. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.
- •10. Acute contrast induced nephropathy
- •11. Temperature >38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
- •12. Serum potassium <3.5 mEq/L (3.0-3.4 mEq/L will be allowed if parenteral supplemental potassium is being administered)
- •13. Ongoing or planned IV therapy for AHFS with positive inotropic agents, vasopressors, vasodilators, or mechanical support (intraaortic balloon pump, endotracheal intubation, ventricular assist device) with the exception of IV nitrates
- •14. BNP <500 pg/mL or NT-pro-BNP <2000 pg/mL
- •15. Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis
- •16. Severe pulmonary disease (as evidenced by pre-admission or current oral steroid dependency, current treatment with IV steroids, or previous history of CO2 retention or intubation for acute exacerbation)
- •17. Significant stenotic valvular disease (severe aortic stenosis, mitral stenosis)
- •18. Heart transplant recipient or admitted for cardiac transplantation
- •19. Clinical evidence of acute coronary syndrome in the 2 weeks prior to screening
- •20. AHFS due to significant arrhythmias (ventricular tachycardia, bradyarrhythmias with slow ventricular rate [<45 beats per minute] or atrial fibrillation/flutter with a rapid ventricular response of >120 beats per minute)
- •21. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy. This criterion does not include restrictive patterns seen on Doppler.
- •22. Known hepatic impairment (total bilirubin >3 mg/dL, albumin <2.8 mg/dL, or increased ammonia levels if performed)
- •23. Non-cardiac pulmonary edema, including suspected sepsis
- •24. Administration of an investigational drug or device, or participation in another trial, within 30 days before randomization
- •25. Current or anticipated therapy with atanazavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole
- •26. Systolic blood pressure >160 mmHg at randomization
- •27. Inability to follow instructions or comply with follow-up procedures
- •28. Allergy to soybean oil or eggs or benzodiazepines
- •29. History of seizure (except febrile seizure)
- •30. Stroke within 2 years
- •31. History of or current brain tumor of any etiology
- •32. Brain surgery within 2 years
- •33. Encephalitis/meningitis within 2 years
- •34. History of penetrating head trauma
- •35. Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years
- •36. History of drug or alcohol abuse or at risk for alcohol withdrawal seizures
- •37. Advanced Alzheimer’s disease
- •38. Advanced multiple sclerosis
- •39. Hgb <8 g/dL, or Hct <25%, or the need for a blood transfusion
- •40. Previous exposure to KW-3902
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