EUCTR2017-000394-36-DE进行中（未招募）1 期
Influences of angiotensin-neprilysin inhibition with Sacubitril/Valsartan (ENTRESTO®) on centrally generated sympathetic activity in heart failure patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
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. Women or men at the age = 18 years, = 80 years and able to give written informed consent
- •2. Heart failure NYHA class II-III
- •3. Ejection fraction of 40 % or less (any measurement made within the past 6 month using echocardiography, MUGA, CT scanning, MRT or ventricular angiography is acceptable, provided no subsequent measurement above 40%)
- •4. ACE inhibitor or ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks before visit 1 (screening)
- •5. Stable dose of a beta-blocker for at least 4 weeks before visit 1 unless contraindicated or not tolerated
- •6. Patient has to be in sinus rhythm
- •7. Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
- •8. Women without childbearing potential defined by:
- •at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
- •hysterectomy or uterine agenesis or
- •= 50 years and in postmenopausal state = 1 year or
- •< 50 years and in postmenopausal state = 1 year with serum FSH > 40 IU/l and serum estrogen< 30 ng/l or a negative estrogen test
- •Women of childbearing potential with a negative urine ß-HCG pregnancy test at screening who agree to meet one of the following criteria from the time of screening, during the study and for a period of 7 days following the last administration of study medication:
- •correct use of at least an acceptable effective contraceptive measure. The following are deemed acceptable in this study: hormonal contraceptives (combined oral contraceptives and estrogen-free pills with desogestrel, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), intrauterine device (IUS)
- •true abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception)
- •sexual relationship only with female partners and/or sterile male partners
- •9. Signed written informed consent and willingness to comply with treatment and follow- up procedures.
- •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 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •1. History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACE inhibitors (ACE-Is), ARBs, or neprilysin inhibitors, as well as known or suspected contraindications to the study drugs
- •2. Known history of angioedema
- •3. Recent acute decompensated heart failure within 2 months before screening (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
- •4. Symptomatic hypotension and/or office systolic BP <110 mmHg at visit 1
- •5. Combined intake of an ACE inhibitor and ARB over the last 4 weeks before visit 1
- •6. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² as measured by the simplified MDRD forumla
- •7. Concomitant medication with Aliskiren in patients with Diabetes or patients with eGFR < 60 mL/min/1.73 m² as measured by the simplified MDRD forumla
- •8. Serum potassium >5.2 mmol/L at Visit 1 (screening)
- •9. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid, or other major cardiovascular surgery, PCI, or carotid angioplasty within the 3 months before screening
- •10. History of heart transplant or on a transplant list or with LV assistance device
- •11. History of severe pulmonary disease
- •12. Documented untreated ventricular arrhythmia with syncopal episodes within the 3 months prior to Visit 1
- •13. Presence of hemodynamically significant mitral and/or aortic valve disease/ left ventricular outflow tract obstruction, except mitral regurgitation secondary to LV dilatation
- •14. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs
- •15. Evidence of hepatic disease as determined by any one of the following: aspartate aminotransferase or alanine aminotransferase values exceeding 2× upper limit of normal at Visit 1, history of hepatic encephalopathy, history of esophageal varices, or history of porto-caval shunt
- •16. Contraindications precluding microneurography measurements, such as relevant peripheral neuropathy as judged by the investigator
- •17. Pregnancy or lactation period
- •18. Current participation in any other clinical trial or participation in another clinical trial within 30 days before screening
- •19. Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal products
- •20. Vulnerable subjects (i.e. persons under any administrative or legal supervision or persons kept in detention)
研究者
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