EUCTR2007-004271-19-FR进行中（未招募）1 期
A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-ControlledStudy to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure. - RELAX-AHF
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •2. Male or female = 18 years of age, with body weight <160 kg
- •3. Systolic blood pressure > 125 mmHg at the start of screening and at the end of screening
- •4. Hospitalized for AHF. AHF is defined as including all of the following measured at any
- •time between presentation (including the emergency department [ED]) and the end of
- •a. Dyspnea at rest or with minimal exertion
- •b. Pulmonary congestion on chest radiograph
- •c. BNP = 350pg/mL or NT-pro-BNP =1400 pg/mL
- •5. Able to be randomized within 16 hours from presentation to the hospital, including the ED
- •6. Received IV furosemide of at least 40 mg (or equivalent) at any time between admission
- •to emergency services (either ambulance or hospital, including the ED) and the start of
- •screening for the study
- •7. Impaired renal function defined as an estimated glomerular filtration rate (eGFR) on
- •admission between 30-75 mL/min/1.73 m2, calculated using the simplified Modification
- •of Diet in Renal Disease (sMDRD) equation
- •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. Pregnant or breast-feeding women (women of child bearing potential must have the
- •results of a negative pregnancy test recorded prior to study drug administration)
- •2. Administration of intravenous radiographic contrast agent within 72 hours prior to
- •screening or acute contrast-induced nephropathy at the time of screening
- •3. Temperature >38°C (oral or equivalent) or sepsis or active infection requiring IV anti-
- •microbial treatment
- •4. Current (within 2 hours prior to screening) or planned (through the completion of study
- •drug infusion) treatment with any IV therapies, including vasodilators (including
- •nesiritide), positive inotropic agents and vasopressors, or mechanical support (intra-aortic
- •balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist
- •device), with the exception of IV nitrates at a dose of < 0.1 mg/kg/hr if the patient has a
- •systolic BP > 150 mmHg at screening
- •5. Current or planned ultrafiltration, hemofiltration, or dialysis
- •6. Known significant pulmonary disease
- •7. Known significant valvular disease (including any of the following: severe aortic stenosis
- •[AVA < 1.0 or peak gradient > 50 on prior or current echocardiogram], severe aortic
- •regurgitation, or severe mitral stenosis)
- •8. Any organ transplant recipient, or patient currently listed for transplant or admitted for
- •any transplantation
- •9. Major surgery within 30 days
- •10. Hematocrit < 25% or blood transfusion in the prior 14 days or active, life-threatening GI
- •11. Major neurologic event, including cerebrovascular events, in the prior 60 days
- •12. Clinical diagnosis of acute coronary syndrome within 45 days prior to screening
- •(including the present admission) as determined by both clinical and enzymatic criteria
- •13. Troponin > 3 times the upper limit of normal (including borderline/intermediate)
- •between presentation and screening.
- •14. AHF due to significant arrhythmias (including any of the following: ventricular
- •tachycardia, bradyarrhythmias with ventricular rate <45 beats per minute or any second
- •or third degree AV block or atrial fibrillation/flutter with ventricular response of >120
- •beats per minute)
- •15. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive
- •cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler
- •echocardiographic assessments of diastolic function)
- •16. Known hepatic impairment
- •17. Non-cardiac pulmonary edema, including suspected sepsis
- •18. Administration of an investigational drug or implantation of investigational device, or
- •participation in another trial, within 30 days before screening or previous treatment with
- •19. Inability to follow instructions or comply with follow-up procedures
研究者
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