EUCTR2011-001117-13-ES进行中（未招募）1 期
Congestive Heart Failure Cardiopoietic Regenerative Therpapy CHART-1 Trial Efficacy and Safety of Bone Marrow-Derived Mesenchymal Cardiopoietic Cells (C3BS-CQR-1) for the Treatment of Chronic Advanced Ischemic Heart Failure - Congestive Heart failure cArdiopoietic Regenerative Therapy-1 (CHART-1) trial
Celyad SA0 个研究点目标入组 240 人开始时间: 2013年8月29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
- 240
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
入选标准
- •Eligible patients must meet all of the following inclusion criteria:
- •1. Age ? 18 and < 80 years.
- •2. Systolic dysfunction with LVEF ? 35% as assessed by echocardiography.
- •3. Ischemic heart failure without known need for revascularization.
- •4. Total MLHFQ score > 30.
- •5. Ability to perform a Six-Minute Walk Test > 100 m and ? 400 m.
- •6. History of hospitalization for HF within 12 months prior to screening or treatment in an out-patient clinic with intravenous vasoactive therapy (including vasodilators, positive inotropic agents and vasopressors) or diuretics for worsening HF within 12 months prior to screening.
- •7. Be or must have been within the previous 12 months in NYHA class III or IV or INTERMACS class 4, 5, 6 or 7, and at the time of inclusion, must be at least in NYHA class II or greater.
- •8. Use of ACE inhibitor and/or ARB; and beta blocker, for at least 3 months prior to screening visit, unless intolerant or contraindicated.
- •9. Stable dosing of ACE inhibitor, ARB, beta blocker, aldosterone blocker, and diuretics for at least one month prior to screening visit, defined as ?50% change in total dose of each agent.
- •10. Willing and able to give written informed consent.
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Eligible patients must meet none of the following exclusion criteria:
- •1. Women who are pregnant, confirmed by a positive urine or serum hCG laboratory test at screening.
- •2. Women of child-bearing potential without a negative serum or urine pregnancy test at screening or who are not practicing a reliable form of birth control. Women who are postmenopausal (12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH level > 40 mIU/ml or 6 weeks post surgical bilateral oophorectomy) or surgically sterile are not considered to be of child-bearing potential. Reliable contraception includes surgical sterilization, hormonal contraception, or double-barrier methods.
- •3. Men refusing to exercise a reliable form of contraception.
- •4. Myocardial infarction, unstable angina or percutaneous coronary intervention (PCI) within 90 days prior to screening, or CABG surgery within 180 days prior to screening.
- •5. Patient on a cardiac transplant list or previously received any solid organ transplant.
- •6. Previously underwent cardiac surgery with remodeling procedure, left ventricular assist device placement or cardiomyoplasty. This exclusion does not apply to patients who underwent ventricularplasty without placements device >1 year ago.
- •7. Patient has undergone cardiac resynchronization therapy (CRT) within 6 months (180 days) prior to screening.
- •8. Severe uncontrolled HF requiring need for intensive intravenous diuretics or inotropic support within 1 month prior to screening.
- •9. Inability to perform a Six-Minute Walk Test due to physical limitations other than HF including:
- •a. Severe peripheral vascular disease
- •b. Severe pulmonary disease or chronic obstructive pulmonary disease (COPD) limiting exercise
- •c. Orthopedic limitations, severe muscular diseases, any other joint or muscular disease or neurological disorder (such as an old stroke or neuropathy) limiting the ability to walk for 6 minutes.
- •10. Dependence on chronic oral steroid therapy.
- •11. Stroke or transient ischemic attack leading to limitations in lower extremities or occurring within 180 days prior to screening.
- •12. Active myocarditis, constrictive pericarditis, restrictive, hypertrophic or congenital cardiomyopathy.
- •13. BMI < 19 or > 45.
- •14. Left ventricular thrombus.
- •15. Left ventricular wall thickness < 8mm visualized in more than 50% of LV, and defined as a LV no-go zone
- •16. LV aneurysm or candidate for surgical aneurysmectomy.
- •17. Sustained VT or VF which led to AICD therapy (shock) within 3 months prior to screening.
- •18. Primary significant organic valvular heart disease.
- •19. Moderate to severe aortic valve disease precluding catheter entry into the LV.
- •20. Mechanical prosthetic valve in aortic or mitral position.
- •21. Chronic infection or active malignancy.
- •22. Patient has compromised renal function as reflected by a serum creatinine level >3.0 mg/dL (>0.265 mmol/l) or is currently on dialysis.
- •23. Hematocrit < 28%.
- •24. Atherosclerosis and/or tortuosity of the aorta, iliac or femoral arteries of
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