EUCTR2017-004073-14-IT进行中（未招募）1 期
A phase III randomised, double-blind trial to evaluate the effect of 12weeks treatment of once daily EMPagliflozin 10 mg compared with placeboon ExeRcise ability and heart failure symptoms, In patients with chronicHeArt FaiLure with reduced Ejection Fraction (HFrEF) (EMPERIAL-reduced) - EMPERIAL – reduced
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 个研究点目标入组 707 人开始时间: 2021年2月9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
- 707
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. Of full age of consent (according to local legislation, usually = 18
- •years) at screening.
- •2. Male or female patients. Women of childbearing potential (WOCBP)1
- •must be ready and able to use highly effective methods of birth control
- •per ICH M3 (R2) that result in a low failure rate of less than 1% per year
- •when used consistently and correctly. A list of contraception methods
- •meeting these criteria is provided in the patient information.
- •3. Signed and dated written informed consent in accordance with ICHGCP
- •and local legislation prior to admission to the trial
- •4. 6MWT distance =350 m at screening and at baseline.
- •5. Patients with chronic HF diagnosed for at least 3 months before Visit 1
- •and currently in NYHA class II-IV
- •6. Chronic HF with reduced EF defined as LVEF = 40 % as per
- •echocardiography at Visit 1 as per local reading (obtained under stable
- •condition).
- •7. Elevated NT-proBNP > 450 pg/ml for patients without atrial fibrillation (AF) OR NT-proBNP > 600 pg/ml for patients with AF as analysed at the Central laboratory at Visit 1
- •8. Patients must be clinically stable and on appropriate and stable dose
- •of medical therapy for HF (such as ACEi, ARB, ß-blocker, oral diuretics,
- •MRA, ARNI, ivabradine), consistent with prevailing CV guidelines, stable
- •for at least 4 weeks prior to Visit 1(screening) with the exception of
- •diuretics which must have been stable for at least two weeks prior to
- •Visit 1. The investigator must document the reason in case the patient is not on such medication or if not on target dose of any heart failure medication as per local guidelines.
- •9. Clinically stable at randomization with no signs of heart failure
- •decompensation (as per investigator judgement).
- •10. Appropriate use of medical devices such as cardioverter defibrillator
- •(ICD) or a cardiac resynchronization therapy (CRT) consistent with
- •prevailing local or international CV guidelines, and if a device is required,
- •it must have been implanted for at least 3 months prior to visit 1 for CRT
- •and 1 month prior to visit 1 for ICD.
- •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 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Myocardial infarction (increase in cardiac enzymes in combination
- •with symptoms of ischaemia or newly developed ischaemic ECG
- •changes), coronary artery bypass graft surgery or other major
- •cardiovascular surgery, stroke or TIA in past 90 days prior to Visit 1
- •2. Acute decompensated HF (exacerbation of chronic HF) requiring
- •intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left
- •ventricular assist device within 4 weeks prior to Visit 1, and/or during
- •screening period until Visit 2
- •3. Previous or current randomisation in another Empaglifozin Heart Failure
- •trial (i.e. studies 1245.110, 1245.121, 1245-0167)
- •4. Type 1 Diabetes Mellitus (T1DM)
- •5. Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2
- •(CKD-EPIcr) or requiring dialysis, as determined at Visit 1
- •6. Symptomatic hypotension or a SBP < 100 mmHg at Visit 1 or 2
- •7. Systolic blood pressure (SBP) = 180 mmHg at Visit 1 or 2, or SBP
- •>160mmHg at both Visit 1 and 2
- •8. Atrial fibrillation or atrial flutter with a resting heart rate >110 bpm
- •documented by ECG at Visit 1 (Screening)
- •9. Unstable angina pectoris in past 30 days prior to Visit 1
- •10. Largest distance walked in 6 minutes (6MWTD) at baseline <100m.
- •11. Any presence of condition that precludes exercise testing such as:
- •- claudication,
- •- uncontrolled (according to investigator judgement) bradyarrhythmia or
- •tachyarrhythmia,
- •- significant musculoskeletal disease,
- •- primary pulmonary hypertension,
- •- severe obesity (body mass index =40.0 kg/m2),
- •- orthopedic conditions that limit the ability to walk (such as arthritis in
- •the leg, knee or hip injuries)
- •- amputation with artificial limb without stable prosthesis function for
- •the past 3 months
- •- Any condition that, in the opinion of the investigator, would
- •contraindicate the assessment of 6MWT
- •12. Patients in a structured (according to Investigator judgement)
- •exercise training program in the 1 month prior to screening or planned
- •to start one during the course of this trial.
- •13. Planned implantation of ICD or CRT during the course of the trial.
- •14. Treatment with i.v. iron therapy or erythropoietin within 3 months
- •prior to screening
- •15. Treatment with i.v. iron therapy or erythropoietin within 3 months
- •prior to screening
- •16. Further exclusion criteria applies
研究者
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