EUCTR2008-003786-20-PL进行中（未招募）不适用
A Double-Blind, Placebo-Controlled, Randomized, Multi-Center, Dose-Finding Study of SLV320, a Selective A1 Adenosine Receptor Antagonist, to Evaluate the Effect on Renal Function and Safety in Subjects Hospitalized with Acute Decompensated Heart Failure and Renal Dysfunction (Reno-Defend 1)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
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
- •In order to be eligible for the study, subjects should fulfill the following criteria at the Screening visit:
- •1. Be capable of understanding the nature of the study and be willing to participate, as documented by signed written informed consent or signed informed consent by a legally authorized representative.
- •2 .Be 18 years or older (male or female).
- •3. If female, be surgically sterile (bilateral oophorectomy and/or hysterectomy) or be at least one year postmenopausal as judged by the Investigator.
- •4. Have renal dysfunction (defined as estimated eGFR of 20–80 mL/min [Cockcroft-Gault formula]).
- •5.Have BNP =400 pg/mL or NT-pro-BNP >2000 pg/mL.
- •6. Have a history of systolic or diastolic chronic heart failure of at least 14 days duration for which loop diuretic therapy has been prescribed.
- •7. Have clinical evidence of volume overload manifested by at least two of the following features:
- •(a) dyspnea
- •(c) peripheral edema and/or pre-sacral edema
- •(d) increased jugular venous distension (>8 cm)
- •(e) chest X-ray consistent with CHF.
- •8. Require hospitalization for treatment of the current episode of ADHF with I.V. diuretics and
- •-Have received at least 40 mg I.V. furosemide (or equivalent) for the treatment of the current episode of ADHF prior to the start of the initial study drug infusion unless a rationale for a lower dose is provided by the enrolling Investigator, and
- •-Receives the first study treatment within 24 hours (± four hours) following presentation to the hospital (including the emergency department) for this episode of ADHF.
- •9. Anticipated need for I.V. furosemide =40 mg/day (or equivalent dose of I.V. loop diuretic) for at least 24 hours after start of study drug
- •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
- •Subjects are excluded from participating in the study if they:
- •1. Are women of child-bearing potential.
- •2. Have low output syndrome, defined as having the need for treatment with I.V. inotropes or vasopressors.
- •3. Have systolic blood pressure <95 mmHg at the time of randomization.
- •4. Have body temperature >38°C (100.4°F) at the time of randomization.
- •5. Need mechanical ventilation.
- •6. Have significant stenotic valvular disease (severe aortic or mitral stenosis).
- •7. Have clinical evidence of acute coronary syndromes in the two weeks prior to screening.
- •8. Have myocardial infarction or hemodynamically destabilizing significant arrythmias (ventricular tachycardia, bradyarrythmias with slow ventricular rate [<45 bpm] or atrial fibrillation/flutter with a rapid ventricular response of >130 bpm), or electrocardiographic evidence of 2nd degree heart block (Mobitz Type II) or 3rd degree AV-block in the absence of a pacemaker, within 30 days of screening.
- •9. Have acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy.
- •10. Have serum potassium <3.5 mEq/L and/or serum sodium <130 mEq/L. Serum potassium 3.0–3.4 mEq/L will be allowed if parenteral supplemental potassium is being administered.
- •11. Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =3 times the upper limit of normal; and/or total bilirubin >3 mg/dL.
- •12. Have clinically significant laboratory abnormalities or medical conditions which, in the opinion of the Investigator, make them unsuitable for evaluation in the study.
- •13. Any heart, lung, kidney, or liver transplant recipient or are admitted for these transplantations.
- •14. Have ongoing or planned treatment with ultrafiltration, hemofiltration or dialysis.
- •15. Have implantation of a cardiac defibrillator or cardiac resynchronization device (pacemaker) or temporary pacing wire within seven days of screening.
- •16.Have non-cardiac pulmonary edema, including suspected sepsis
- •17. Have a known risk for seizures with history of any of the following:
- •- stroke within two years, or transient ischemic attack within six months, prior to screening.
- •- seizures (except febrile seizure)
- •- brain tumor of any etiology (or current brain tumor)
- •- encephalitis/meningitis within the previous two years
- •- penetrating head trauma
- •- closed head injury with loss of consciousness of over 30 minutes within the previous two years
- •- brain surgery within the previous two years
- •- alcohol withdrawal seizures (or are at risk of alcohol withdrawal seizures)
- •18. Have an increased risk for seizure (as determined by the Investigator) due to unstable condition resulting in widely fluctuating oxygen, glucose or electrolyte levels.
- •19. Have advanced Alzheimer's disease.
- •20. Have advanced multiple sclerosis.
- •21.Have a history of hypoglycemia unawareness.
- •22. Have received I.V. contrast dye within two weeks prior to Day 1, or are expected to receive I.V. contrast during the treatment period of the study.
- •23. Have a history of acute contrast-induced nephropathy (increase of serum creatinine >0.5 mg/dL within 48 hours of contrast exposure).
- •24. Have had administration of an investigational drug or device, or have participated in an investigational trial, within 30 days prior to randomization.
- •25. Have evidence of malignancy, within 6 months prior to screening. Subjects with a history of stable prostate cancer, basal cell carcinoma, or fewer than three squamous cell carcinomas
研究者
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