CTIS2023-506283-13-00招募中1 期
se of determination of drug levels to optimize pharmacotherapy of heart failure
Fakultni Nemocnice Ostrava0 个研究点目标入组 100 人开始时间: 2023年8月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •HFrEF with already established or newly started treatment with the listed medicinal products, Male and female patients over 18 years of age, Signed Informed Consent with participation in the study, Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) result at the initial visit and use an acceptable method of contraception with a home control urine pregnancy test every 3 months throughout the duration of the study
排除标准
- •Hypersensitivity to the medicinal substance or to any auxiliary substance, Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - sinus node dysfunction syndrome (including sinoatrial block), Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - severe hypotension (systolic blood pressure <85 mmHg), Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - Prinzmetal angina, Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - untreated pheochromocytoma, Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - metabolic acidosis, Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - severe peripheral arterial circulation disorders, Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - concurrent intravenous treatment with verapamil or diltiazem, Additional exclusion criteria for patients using Spironolactone - anuria, Additional exclusion criteria for patients using Spironolactone - acute renal failure, Additional exclusion criteria for patients using Spironolactone - severe renal impairment (estimated glomerular filtration rate <10 ml/min), Pregnant and breastfeeding women, Additional exclusion criteria for patients using Spironolactone - hyperkalemia >5.5 mmol/l, Additional exclusion criteria for patients using Spironolactone - hyponatremia <125 mmol/l, Additional exclusion criteria for patients using Spironolactone - Addison's disease, Additional exclusion criteria for patients using Spironolactone - concurrent use of eplerenone or other potassium-sparing diuretics, Additional exclusion criteria for patients using Spironolactone - porphyria, Additional exclusion criteria for patients using Sacubitril/Valsartan - concomitant use with ACE inhibitors, Additional exclusion criteria for patients using Sacubitril/Valsartan - angioedema related to previous ACE inhibitor treatment or a history of ARB treatment, Additional exclusion criteria for patients using Sacubitril/Valsartan - hereditary or idiopathic angioedema, Additional exclusion criteria for patients using Sacubitril/Valsartan - concomitant use with medicinal products containing Aliskiren in patients with diabetes mellitus or in patients with impaired renal function (eGFR <60 ml/min/1.73 m2), Additional exclusion criteria for patients using Sacubitril/Valsartan - severe liver dysfunction, biliary cirrhosis and cholestasis, Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - Unstable or decompensated heart failure belonging to the NYHA IV group according to the New York Heart Association classification, requiring intravenous inotropic support, Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - Clinically manifest liver dysfunction, Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - History of bronchospasm or asthma, Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - Severe obstructive airways disease, Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Meto
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