EUCTR2017-002113-64-FI进行中（未招募）1 期
Controlled trial on the short-term effects of sacubitril/valsartan therapy on cardiac oxygen consumption and efficiency of cardiac work in patients with NYHA II-III heart failure and reduced systolic function using 11C-acetate positron emission tomography and echocardiography
ovartis Finland Oy0 个研究点目标入组 60 人开始时间: 2017年10月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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. Voluntary, valid written informed consent (IC) obtained before any study-related assessment is performed.
- •2. Sufficient command of the Finnish or Swedish language to be able to fully understand the ICF and other study information and to be able to communicate with the study personnel.
- •3. Male and female subjects =40 and =80 years of age.
- •4. Documented chronic HF with left ventricle EF 25-35% and NYHA class II-III symptoms.
- •5. Systolic BP 110-160 mmHg at the time of randomization.
- •6. Optimal standard HF therapy according to ESC guidelines, including at a minimum beta-blockers in all subjects, at a stable dose for at least 4 weeks before the first screening visit.
- •7. Valsartan treatment tolerated at a dose of 80 mg or 160 mg BID for at least 4 weeks during the screening/run-in period.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Predicted poor compliance or inability to communicate well with the investigator or the study center personnel.
- •2. Current acute or subacute decompensated HF.
- •3. Presence of acute coronary syndrome, stroke, transient ischemic attack or other major cardiovascular event or cardiovascular procedure within 3 months before screening.
- •4. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after randomization.
- •5. Evidence of clinically significant renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease that may constitute a health risk for the subject and/or would interfere with the evaluation of the results, as judged by the investigator.
- •6. Symptomatic hypotension that persists even after modification of concomitant medication(s), at any time during the screening/run-in period.
- •7. Estimated glomerular filtration rate (eGFR) < 45 ml/min at any time during the screening/run-in period that persists even after modification of concomitant medication(s).
- •8. Serum potassium >5.2 mmol/l at any time during the screening/run-in period that persists even after modification of concomitant medication(s).
- •9. Serum creatinine > 1.5 x ULN (upper limit of normal) at any time during the screening/run-in period that persists even after modification of concomitant medication(s).
- •10. Contraindication to neprilysin inhibitor or ARB (such as previous angioedema or known intolerance).
- •11. Susceptibility to severe allergic reactions or known hypersensitivity to the active substances or to any of the excipients.
- •12. Intake of any medication that could affect the outcome of the study, interfere with the evaluation of the results or constitute a health risk for the study subject, as judged by the investigator.
- •13. Positive serology to human immunodeficiency virus antibodies (HIVAgAb), hepatitis C virus antibodies (HCVAb) or hepatitis B surface antigen (HBsAg) in medical history.
- •14. Unwillingness to use adequate methods of contraception while participating in the study and for 3 months after the last administration of the PET tracer.
- •15. Participation in another clinical drug study within 3 months prior to the first study treatment administration of this study.
- •16. Prior participation in an investigational PET study or other medical or occupational exposure to significant doses of ionizing radiation, as judged by the investigator.
研究者
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