EUCTR2013-002287-11-GR进行中（未招募）不适用
A randomized parallel-group, placebo-controlled, double-blind, multi-center dose finding phase II trial exploring the pharmacodynamic effects, safety and tolerability, and pharmacokinetics of four dose regimens of the oral sGC stimulator BAY 1021189 over 12 weeks in patients with worsening heart failure and reduced ejection fraction. - SOCRATES-REDUCED
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 410
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. Written informed consent signed before any study-specific procedure
- •2. Worsening chronic heart failure requiring hospitalization (or IV diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization:
- •Diagnostic methods:
- •-History of chronic HF: NYHA class II-IV and treatment with standard HF therapy =30 days before hospitalization (or before IV diuretic treatment for HF)
- •- Worsening HF at hospitalization (or at the time of IV diuretic treatment for HF without hospitalization)
- •- NT-proBNP =1000 or BNP =300 pg/mL in sinus rhythm, or NT-proBNP =1600 or BNP =500 pg/mL in A. fib. in local routine labs, and
- •- Symptoms and signs of congestion [clinical or radiographic signs in routine chest x-ray demonstrating pleural effusion, pulmonary congestion (redistribution, interstitial or alveolar edema), or cardiomegaly]
- •- Clinical stabilization defined by
- •- no IV vasodilator for >24h and no IV diuretic for >12h before randomization and
- •- SBP =110 and <160, and resting HR =50 and <100 bpm at randomization
- •- LVEF <45% by echocardiography at randomization
- •3. Ability to understand and follow study-related instructions
- •4. Men or confirmed postmenopausal women or women without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy. Men enrolled in this study must agree to use adequate barrier birth control measures during the treatment period of the study.
- •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 82
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 328
排除标准
- •1. Legal lower age limitations for adults (country specific)
- •2. IV inotropes at any time between hospitalization and randomization
- •3. Concurrent of anticipated nitrate use (all routes, incl. prn) for the treatment of ischemic heart disease or HF, including:
- •- subjects tolerant of and treated with isosorbide dinitrate for chronic HFrEF according to guideline recommendations
- •- subjects requiring nitrates as anti-anginal therapy in addition or alternatively to beta-blockers
- •4. Cardiac comorbidity (either of the following):
- •- Specific HF etiologies, including:
- •- Hypertrophic cardiomyopathy with LV outflow tract obstruction; or
- •- Pericardial disease, such as constrictive pericarditis; or
- •- Infiltrative or inflammatory myocardial disease such as acute myocarditis, amyloidosis, sarcoidosis; or
- •- Valvular heart disease with
- •- severe aortic or primary mitral regurgitation
- •- moderate or severe aortic stenosis
- •- any mitral stenosis requiring surgical repair
- •- active endocarditis
- •- Acute coronary syndrome, including unstable angina, NSTEMI or STEMI, or CABG within 60 days prior to randomization; or
- •- Current indication for PCI or CABG (at the time of randomization)
- •- Significant cardiac ischemia in a stress test within a year of enrollment without revascularization since
- •- Symptomatic carotid stenosis, or TIA or stroke within 30 days prior to randomization
- •- New initiation of CRT within 60 days prior to randomization
- •- Listing for heart transplantation and/or anticipated/implanted ventricular assist device
- •- Complex congenital heart disease
- •5. Non-cardiac comorbidity, indicated by either of the following at the time of randomization
- •- Glomerular filtration rate <30 ml/min/1.73 m2 calculated by MDRD formula
- •- Hepatic insufficiency classified as Child-Pugh B or C
- •- Morbid obesity with a BMI >45 kg/m²
- •- Malignancy or other non-cardiac condition limiting life expectancy to <1 year, per physician judgment
- •- Severe pulmonary disease with either requirement of continuous home oxygen or BEA for massive hemoptysis
- •- Subjects with allergies, intolerance or hypersensitivity to investigational drug or any of the excipients
- •- Medical condition or history thereof that in the opinion of the investigator would impair the ability to complete the planned study procedures
- •6. Concomitant Treatment with a PDE5 inhibitor or sGC stimulator
- •7. Previous (within 30 days of randomization) or concomitant participation in another clinical study with investigational medicinal product(s).
- •8. Close affiliation with the investigational site; e.g., a close relative of the investigator, dependent person (e.g., employee or student of the investigational site).
- •9. Previous assignment to treatment during this study.
研究者
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