NL-OMON38421已完成2 期
A randomized, controlled study to evaluate the safety and cardiovascular effects of Algisyl-LVR* as a method of left ventricular augmentation in patients with dilated cardiomyopathy (AUGMENT-HF) - AUGMENT-HF
oneStar Inc0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
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. The patients must be able and willing to give written informed consent;
- •2. The patients will be adult (age >= 18 years and <= 79 years) males or females;
- •3. The patients must be on stable, evidence-based therapy for heart failure;
- •4. The patients will have a left ventricular ejection fraction equal to or less than 35% via echocardiography, cardiac catheterization, radionuclide scan, or magnetic resonance imaging (measured within the last 30 days);
- •5. The patients will have a left ventricular end diastolic dimension indexed to body surface area (LVEDDi) of 30 to 40mm/m2 (LVEDD/BSA) (measured within the last 30 days);
- •6. Patients must have symptomatic heart failure with a Peak VO2 of 9.0 - 14.5 ml/min/kg (performed using a bicycle ergometer). Patients must perform two CPX tests (within 30 days of randomization and performed at least 20 hours apart) that differ by no more than 15% in the observed value for Peak VO2 and have a mean value of 9.0 - 14.5 ml/min/kg from these two tests;
- •7. Patient*s surgical risk must be considered reasonable and the evaluation of surgical risk should include review of coronary and left ventricular angiography;
- •8. If female, the patients must be (a) post-menopausal, (b) surgically sterile, or (c) using adequate birth control and have a negative serum pregnancy test within 7 days prior to administration of study device.
排除标准
- •1. Patients for whom it is planned to receive CABG, MVR, heart transplantation or LVAD within the next 6 months;
- •2. Patients presenting with cardiogenic shock;
- •3. Patients who have undergone a previous mid-sternotomy surgical procedure are excluded unless the surgeon*s assessment is that the left sided limited thoracotomy is feasible and considered reasonable surgical risk;
- •4. Patients presenting with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis;
- •5. Patient with a history of constrictive pericarditis;
- •6. Patients with a Q wave myocardial infarction (MI) within the last 30 days;
- •7. Patients with a recent history of stroke (within 60 days prior to the surgical procedure);
- •8. A left ventricular (LV) wall thickness of the LV free-wall, at the midventricular level, of less than 8 mm (screening echocardiography must confirm a minimum wall thickness of 8 mm);
- •9. Patients with a serum creatinine > 2.5 mg/dL;
- •10. Clinically significant liver enzyme abnormalities, i.e., AST(SGOT) and ALT (SGPT) more than 2.5 times the upper limit of normal;
- •11. History of severe COPD (i.e., FEV 1< 1 liter or FEV1 < 50% predicted);
- •12. The patients will not be receiving concurrently an investigational Product in another clinical trial or have received an investigational Product in another clinical trial in the 30 days prior to enrollment;
- •13. A life expectancy of less than 1 year or any other condition that, in the opinion of the clinical investigator, might compromise any aspect of the trial.
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