EUCTR2008-006237-27-NL进行中（未招募）1 期
Safety and efficacy of TRC4186 in the treatment of stable heart failure associated with HbA1c >= 6 % or type 2 diabetes receiving oral hypoglycaemic therapy (with or without additional insulin) as an add-on to conventional treatment for heart failure
Torrent Pharmaceuticals Ltd.0 个研究点目标入组 300 人开始时间: 2009年7月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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. Male and female subjects aged = 45 years. Female and male subjects must be of
- •non-childbearing or non-fertile potential, i.e. surgically sterile (bilateral
- •oophorectomy, hysterectomy, bilateral tubal ligation, vasectomy) or post-menopausal
- •for at least one year. Male subjects of fertile potential, must use an effective method
- •of birth control
- •2. Subjects with chronic heart failure stable for last 6 weeks (NYHA class II – III)
- •according to the criteria given in Appendix I (see section 15.1) and on stable
- •medication for heart failure for at least 2 weeks prior to screening, with no change in
- •drug or dose in that period.
- •3. Subjects with established type 2 diabetes mellitus (i.e. receiving oral therapy with or without insulin) or an impaired glucose tolerance (HbA1c should be =6.0% at
- •4. Subjects with NT-proBNP (N-terminal fragment of the a brain natriuretic peptide
- •(BNP)) = 400 pg/mL (subjects with atrial fibrillation NT-proBNP = 1200 pg/mL)
- •5. Subjects receiving a loop, thiazide or thiazide like diuretic (Metolazone,
- •Chlorthalidon, Indapamide and Xipamide) for treating heart failure (HF)
- •6. Subjects able to undergo cardiopulmonary exercise testing
- •7. Subjects able to communicate well with the investigator and to comply with the
- •requirements of the entire study
- •8. Subjects willing to give written informed consent (prior to any study-related
- •procedures being performed) and able to adhere to the study restrictions and
- •assessments schedule.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. CHF caused by myocarditis, cor pulmonale, congenital heart disease, constrictive
- •pericarditis, or hypertrophic or restrictive cardiomyopathy.
- •2. Significant important hemodynamic disease in the investigators opinion, e.g. mitral
- •regurgitation and/or planned for surgery.
- •3. Acute coronary syndrome or coronary revascularization within 3 months
- •4. Angina as symptom limiting treadmill/bicycle exercise.
- •5. Evidence of myocardial ischemia which in the investigator’s opinion requires
- •investigation by angiography with a view to coronary revascularization
- •6. Presence of a left ventricular (LV) aneurysm.
- •7. History of ventricular fibrillation or symptomatic sustained ventricular tachycardia
- •without clear reversible precipitating cause (eg:- Severe hypokalemia [Serum
- •potassium < 3.0 mmol/L] or acute myocardial ischemia/ infarction) in past 12 months
- •unless treated with an implantable defibrillator.
- •8. Second-degree or third-degree heart block (unless treated with a pacemaker)
- •9. Patients scheduled for CRT or who have received CRT in past 3 months.
- •10. Left ventricular assist device (or an activated minute ventilation pacemaker)
- •11. Gross obesity (body mass index (BMI) > 40 kg/m2).
- •12. Pulmonary function (FEV1) less than 60 % of predicted or requiring long-term
- •corticosteroids.
- •13. Type I diabetes.
- •14. Severe joint disease or peripheral arterial disease sufficient to impede exercise
- •15. History of systemic and other vascular inflammatory disease.
- •16. Uncontrolled hypertension (systolic blood pressure = 160 mmHg under
- •antihypertensive treatment).
- •17. Screening liver enzyme test (AST or ALT) exceeding 3 times the upper limit of
- •normal range or hepatic impairment of Child-Pugh class C
- •18. Glomerular filtration rate (eGFR) < 30 ml/min.
- •19. Haemoglobin < 10.0 gm/dl
- •20. HbA1c > 10 %
- •21. Gastrointestinal disorder that could interfere with study drug absorption
- •22. Medical history of chronic hepatitis B, C
- •23. Medical history of HIV seropositivity
- •24. Pregnancy or nursing females
- •25. Any cancer disease, except non-invasive skin cancer (e. g. actinic keratosis or basal cell carcinoma), or any other condition that may preclude full participation in the
- •study or that limit survival
- •26. Prior history of radiation and chemotherapy for malignancies
- •27. Known hypersensitivity to any ingredient of the study medication
- •28. Current participation (including prior 30 days) in any other therapeutic clinical trial
- •29. Unwilling or unable to comply with protocol
研究者
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