EUCTR2012-001818-42-LV进行中（未招募）1 期
A Double-blind, Randomized, Sham–procedure–controlled, Parallel-group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (rexlemestrocel-L) in Patients with Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology: DREAM HF-1 - DREAM HF-1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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. The patient is 18 to 80 years of age, inclusive; both men and women will be enrolled.
- •2. The patient has a diagnosis of chronic HF of ischemic or nonischemic etiology for at least 6 months before the initiation of screening procedures, with NYHA Functional Class II or Functional Class III symptoms. Chronic HF of ischemic etiology includes epicardial CAD defined as documented stenosis of at least 50% in one or more major epicardial coronary arteries or documented prior MI.
- •3. The patient is on stable, optimally tolerated dosages of HF therapies including beta-blockers (approved for country-specific usage), ACE inhibitors or angiotensin-receptor blockers (ARBs), and/or aldosterone antagonists, without change in dose for at least 1 month prior to study intervention (ie, hospitalization on day 0 for index cardiac catheterization with or without intracardiac mapping and cell
- •4. The patient is on a stable, outpatient, oral diuretic dosing regimen in which the patient remains clinically stable during the screening period (flexible diuretic dosing that allows the patient to titrate the dose or add a dose of a second diuretic during screening is permitted, provided that the dosing regimen is not further altered and the patient remains stable during this period) or the patient is not on a regular dose of diuretics but takes diuretics as needed based on daily weight or the appearance of symptoms.
- •5. The patient is not a candidate for either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery as determined by the principal investigator (or designee) during screening.
- •6. The patient may be on the cardiac transplant list. However, he/she must have low priority status with low probability of having a transplant procedure performed over the next 12 months (ie, cannot be UNOS status 1A or 1B).
- •7. The patient has a LVEF of 40% or less as measured by 2-D echocardiogram, or 35% or less as measured by RVG within 42 days prior to study intervention (ie, hospitalization on day 0 for index cardiac catheterization with or without intracardiac mapping and cell delivery).
- •8. The patient has 1 or more of the following:
- •at least 1 HF hospitalization more than 1 month, but 9 months or less before initiation of screening procedures
- •at least 1 outpatient visit requiring IV diuretic, vasodilator, and/or positive inotropic therapy more than 1 month, but 9 months or less before initiation of screening procedures
- •plasma levels of NT-pro-BNP greater than 1000 pg/mL (1000 ng/L SI units; 118 pmol/L) or 1200 pg/mL (1200 ng/L SI units; 141.6 pmol/L) for patients with atrial fibrillation
- •9. If the patient has an ICD (or any implanted device capable of defibrillation) in place, the procedure must have occurred at least 1 month before initiation of screening procedures.
- •10. If the patient has had CRT, the procedure must have occurred at least 3 months before screening.
- •11. The patient has an LV diastolic wall thickness of at least 8 mm at the potential target site for cell injection.
- •12. Women must be surgically sterile, 1 year post-menopausal, or must have a negative urine pregnancy test at screening.
- •13.Women must be surgically sterile, 1 year post-menopausal, or, if of childbearing potential, currently using a medically accepted method of contraception, and must agree to continue to use this method of contraception after initiation of screening procedures and for 6 months after study intervention (ie, hos
排除标准
- •Subjects will not be enrolled into this study if they meet ANY of the following criteria:
- •1.The patient has NYHA Functional Class I or Functional Class IV symptoms.
- •2.The patient has had an acute MI within 1 month before initiation of the screening procedures.
- •3.The patient has unstable angina pectoris within 1 month before initiation of screening procedures; unstable angina is defined as the occurrence of chest pain more frequently than usual, pain at rest or upon minimal exertion, or protracted episodes of pain without any discernible trigger, and/or chest pain that persists despite use of vasodilatory therapy (eg, nitroglycerin) and or aggravation of stable angina or new onset angina.
- •4.The patient has peri-/postpartum cardiomyopathy.
- •5.The patient has ischemic or hemorrhagic stroke as diagnosed by CT or MRI within 3 months prior to study enrollment.
- •6.The patient has had coronary arterial or peripheral arterial revascularization procedure within 2 months before initiation of screening procedures.
- •7.The patient has had IV therapy with diuretic, vasodilator, and/or positive inotropes or aquapheresis within 1 month before initiation of screening procedures, and/or during the screening period.
- •8.The patient, who in the absence of an ICD (or any implanted device capable of defibrillation), has a history of malignant ventricular arrhythmia or sustained ventricular tachycardia (VT), with sustained VT demonstrated by QRS complexes wider than 120 milliseconds, lasting more than 30 seconds, and with a rate of more than 100 beats per minute on screening ECG or other data supporting this diagnosis.
- •9.The patient has restrictive, obstructive, or infiltrative CM, pericardial constriction, amyloidosis, or uncorrected thyroid disease.
- •10.The patient has moderate to severe aortic stenosis as determined by echocardiography-Doppler assessment with a valve area less than 1.0 cm2.
- •11.The patient requires valve or other cardiac (eg, pericardectomy) surgery.
- •12.The patient has had LV reduction surgery, implanted LVAD, or cardiac transplantation. The patient may be on the cardiac transplant list, but must have low probability of having a transplant procedure over the next 12 months.
- •13.The patient has an LV thrombus diagnosed by echocardiography, left ventriculogram, or other imaging.
- •14.The patient has cardiogenic shock that is dependent upon mechanical or inotropic support at the time of study intervention (ie, hospitalization on day 0 for index cardiac catheterization with or without intracardiac mapping and cell delivery), as defined by Killip Class IV physiology indicative of cardiogenic shock and/or requirement of intra-aortic balloon pump or IV inotropic support for the maintenance of mean arterial blood pressure at least 60 mmHg.
- •15.The patient is known to have unprotected left main coronary artery disease (CAD) greater than 50%.
- •16.The patient has known hypersensitivity to radiocontrast media or dimethyl sulfoxide (DMSO), murine, and/or bovine products, with the exception of patients with mild hypersensitivity to radiocontrast media, who may be pretreated with corticosteroids and/or antihistamines
- •17.The patient has a known active malignancy within the past 3 years except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that has been definitively treated.
- •18.The patient has acute bacterial or viral infectious disease, or acute exacerbation of a chronic infectious disea
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