NL-OMON33519尚未招募2 期
Safety and efficacy of TRC4186 in the treatment of stable heart failure associated with HbA1c >= 6.5 % or type 2 diabetes receiving oral hypoglycaemic therapy (with or without additional insulin) as an add-on to conventional treatment for heart failure - Not applicable
Torrent Pharmaceuticals Ltd.0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
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 99（—）
入选标准
- •1. Male and female subjects aged >= 45 years. Female and male subjects must be of non-childbearing potential 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 stable chronic heart failure for 3 months (NYHA class II - III) according to the criteria given in Appendix I and on stable medication for at least 6 weeks.
- •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 6.5% -10.0% at screening)
- •4. Subjects with NT-proBNP (N-terminal fragment of the a brain natriuretic peptide (BNP)) >= 600 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
- •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.
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 the symptom limiting treadmill/bicycle exercise
- •5. Evidence of myocardial ischemia in ECG during CPET
- •6. Presence of a left ventricular (LV) aneurysm
- •7. History of symptomatic or sustained ventricular fibrillation or ventricular tachycardia unless treated with a
- •defibrillator
- •8. Second-degree or third-degree heart block (unless treated with a pacemaker), LBBB and patients receiving
- •9. Left ventricular assist device (or an activated minute ventilation pacemaker)
- •10. Gross obesity (body mass index (BMI) > 40 kg/m2)
- •11. Pulmonary function (FEV1) less than 60 % of predicted or requiring long-term corticosteroids
- •12. Type I diabetes
- •13. Severe joint disease or peripheral arterial disease sufficient to impede exercise testing
- •14. History of systemic and other vascular inflammatory disease
- •15. Uncontrolled hypertension (systolic blood pressure >= 160 mmHg under antihypertensive treatment)
- •16. Screening liver enzyme test (AST or ALT) exceeding 3 times the upper limit of normal range or hepatic
- •impairment of Child-Pugh class C
- •17. Serum creatinine > 1.6 mg /dl or glomerular filtration rate (eGFR) < 40 ml/min
- •18. Hemoglobin < 10.5 mg%.
- •19. Gastrointestinal disorder that could interfere with study drug absorption
- •20. Medical history of Chronic hepatitis B, C
- •21. Medical history of HIV seropositivity
- •22. Pregnancy or nursing females
- •23. 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
- •24. Prior history of radiation and chemotherapy for malignancies
- •25. Known hypersensitivity to any ingredient of the study medication
- •26. Current participation (including prior 30 days) in any other therapeutic clinical trial
- •27. Unwilling or unable to comply with protocol
研究者
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