EUCTR2016-003839-38-IT进行中（未招募）1 期
A multicenter, randomized, placebo-controlled, parallel group, double blind, dose-finding Phase II trial to study the efficacy, safety, pharmacokinetic and pharmacodynamic effects of the oral partial adenosine A1 receptor agonist neladenoson bialanate over 20 weeks in patients with chronic heart failure with reduced ejection fraction - PANTHEO
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BAYER AG
- 入组人数
- 427
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. Men or women aged 18 years and older
- •2. Diagnosis of chronic heart failure (CHF), NYHA class II-IV, LVEF = 35% assessed by any imaging modality (e.g. echocardiography, cardiac magnetic resonance [CMR], cine levocardiography) within 6 months prior to run-in: if several values are available the last assessment of EF should be = 35%.
- •3. One of the following (or both),
- •a) Worsening CHF requiring hospitalization or an unscheduled outpatient visit in the last 3 months, both requiring initiation or intensification of heart failure therapy and with either:
- •o BNP = 100 pg/mL or NT-proBNP =400 pg/mL (sinus rhythm) or
- •o BNP = 300 pg/mL or NT-proBNP =1200 pg/mL (atrial fibrillation)
- •b) at any time in the past 4 weeks one of:
- •o BNP = 300 pg/mL or NT-proBNP = 1200 pg/mL (sinus rhythm)
- •o BNP = 600 pg/mL or NT-proBNP = 2400 pg/mL (atrial fibrillation)
- •For patients on treatment with angiotensin receptor-neprilysin inhibitors (ARNIs), e.g. Entresto only NT-proBNP values can be used to assess eligibility.
- •4. Written informed consent before any study-specific procedure
- •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 96
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 288
排除标准
- •1. Acute de-novo heart failure
- •2. Requirement of any of the following 48 hours prior to randomization:
- •IV vasodilating drugs (e.g. nitrates, nitroprusside)
- •- IV natriuretic peptides (e.g. nesiritide, carperitide) - IV positive
- •inotropic agents - IV diuretics - IV antibiotics - Mechanical support (e.g.
- •intra-aortic balloon pump, endotracheal intubation, mechanical
- •ventilation, or any ventricular assist device)
- •3. Any cause of chronic heart failure other than ischemic cardiomyopathy
- •and idiopathic dilated cardiomyopathy
- •4. Known clinically significant persistent coronary ischemia based on
- •medical history, preexisting or current exercise testing
- •5. Occurrence of any of the following within 3 months prior to
- •randomization:
- •o Myocardial infarction
- •o Hospitalization for unstable angina
- •o Stroke or TIA
- •o Coronary artery bypass graft (CABG)
- •o Percutaneous coronary intervention (PCI)
- •o Implantation of a cardiac resynchronization therapy device (CRTD)
- •o Carotid angioplasty
- •6. PCI, CABG or implantation of a CRTD planned between randomization
- •and end of study
- •7. Sustained* systolic blood pressure = 90 mmHg and / or signs and
- •symptoms of hypotension prior to randomization
- •8. Sustained* systolic blood pressure = 160 mmHg
- •9. Sustained* bradycardia with heart rate < 50 beats/minute or
- •tachycardia with heart rate > 100 beats/minute prior to randomization
- •10. Known clinically relevant ventricular arrhythmias (sustained
- •ventricular tachycardia, ventricular flutter or fibrillation) within 3
- •months prior to consent based on either medical history or ICD-testing
- •results (if applicable)
- •11. Clinically relevant permanent or intermittent AV-block > grade II in
- •patients without a permanent pacemaker or ICD / CRT device
- •12. Severe valvular disease with indicated or planned valve repair /
- •replacement
- •13. Listing for heart transplantation and / or anticipated implantation of
- •a ventricular assist device14. Severe pulmonary disease with any of the following:
- •o Requirement of continuous (home) oxygen or
- •o History of COPD = GOLD III or
- •o Use of systemic corticosteroids
- •15. Asthma bronchiale with any of the following:
- •o Symptoms not well-controlled within the past 6 months or
- •o Ever intubated or in an intensive care unit for asthma
- •16. Anemia with hemoglobin < 10 g/dL within 3 months prior to
- •randomization. If several values are available the latest result should be
- •17. Body Mass index (BMI) > 40 kg/m2 at randomization or a history of
- •poor quality LVEF measurement by echocardiography
- •18. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 calculated by Modification of Diet in Renal Disease (MDRD) formula within 3 months prior to randomization. If several values are available
- •the latest result should be used.
- •19. Hepatic insufficiency classified as Child-Pugh B or C, or any of thefollowing:
- 另有 12 项未显示
研究者
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