EUCTR2006-006843-29-PL进行中（未招募）1 期
A multicentre, randomized, double-blind, placebo controlled study of the effects of KW-3902 Injectable Emulsion on heart failure signs and symptoms, diuresis, renal function, and clinical outcomes in subjects hospitalized with worsening renal function and heart failure requiring intravenous therapy. - REACH UP
ovaCardia Inc0 个研究点目标入组 480 人开始时间: 2007年8月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 480
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
入选标准
- •1. Able to provide written informed consent, or a legally authorised representative is able to provide written informed consent.
- •2. Male or female 18 years of age or greater.
- •3. Dyspnea at rest or with minimal exertion at randomisation.
- •4. Fluid overload as manifested by at least one of the following present at randomization:
- •JVP >10 cm OR Pulmonary rales =1/3 up the lung fields, not clearing with cough,
- •OR =2+ peripheral or pre-sacral edema
- •5. Estimated creatinine clearance (CrCl) between 20–60 mL/min using the Cockcroft-Gault equation (corrected for height in edematous subjects =100 kg) based on a serum creatinine (SCr) value drawn within approximately 6 hours of randomization
- •6. Worsening renal function as manifested by one of the following present at randomization:
- •An increase in SCr of at least 25% and at least 0.3 mg/dL from the time of initial presentation for this hospitalization in patients hospitalized with heart failure requiring IV diuretic therapy, OR
- •A documented increase in SCr over the preceding 30 days prior to randomization of at least 40% and at least 0.3 mg/dL in patients being admitted for heart failure requiring IV therapy (these patients must be randomized within 24 hours of
- •7. Anticipated need for IV diuretic treatment for at least 48 hours after the start of study drug
- •8. BNP >500 pg/mL or NT-pro-BNP >2000 pg/mL
- •9. Systolic blood pressure =90 mmHg at randomization. Subjects with systolic blood pressure of 85-89 mmHg at randomization may be included if their usual systolic blood pressure measurements are consistently within 85-89 mmHg 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
- •1. Previous exposure to KW-3902
- •2. Pregnant or breast feeding women. Women of child bearing potential must have a negative serum pregnancy test prior to enrollment.
- •3. Any administration of IV radiographic contrast within 14 days of randomization or any procedures with IV radiographic contrast planned during this hospitalization
- •4. Administration of IV vasodilators within 6 hours of randomization (with the exclusion of nitrates, which are allowed)
- •5. Serum potassium <3.5 meq/L (3.0–3.4 meq/L will be allowed if adequate parenteral supplemental potassium is being administered)
- •6. Ongoing or planned therapy for heart failure with mechanical circulatory support (intra-aortic balloon pump, endotracheal intubation, ventricular assist device) or ventilatory support (including BiPAP or CPAP)
- •7. Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis during this hospitalization
- •8. Rapidly progressive acute renal failure as manifested by an increase in SCr =0.7 mg/dL in a 24-hour period
- •9. Evidence of acute tubular necrosis (urinary sediment, urinary sodium excretion, biopsy, etc.) or post-obstructive nephropathy or other exogenous causes of acute kidney injury, unrelated to heart failure or its treatment (contrast media,cyclosporine, other nephrotoxins)
- •10. 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)
- •11. Significant stenotic mitral or aortic valvular disease
- •12. Heart transplant recipient or admitted for cardiac transplantation or LVAD surgery
- •13. Any major surgery within 2 weeks prior to screening (cardiac or non-cardiac)
- •14. Clinical evidence of acute coronary syndrome in the 2 weeks prior to screening
- •15. Hgb <8 g/dL, Hct <25%, or active bleeding requiring transfusion
- •16. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy. This criterion does not include restrictive patterns seen on Doppler.
- •17. Known hepatic impairment (total bilirubin >3 mg/dL, albumin <2.8 mg/dL, or increased ammonia levels if performed)
- •18. Non-cardiac pulmonary edema
- •19. Temperature >38°C (oral or equivalent)
- •20. Sepsis or active infection requiring IV anti-microbial treatment
- •21. Administration of an investigational drug or device or participation in another trial within 30 days before randomization
- •22. Current or anticipated therapy with atanazavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole
- •23. Administration of any vasopressor or inotropic drug within 72 hours of randomization (with the exception of ongoing dopamine or dobutamine at doses =5 mcg/kg/min or milrinone at a dose of =0.25 mcg/kg/min, which are allowed IF at a stable dose for the preceding 24 hours AND provided there has been no decrease in SCr during the prior 24 hours)
- •24. Inability to follow instructions or comply with study procedures
- •25. Allergy to soybean oil or eggs
- •26. History of sei
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