NCT01643590Unknown2 期
A Phase II Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of JVS-100 Administered by Endomyocardial Injection to Cohorts of Adults With Ischemic Heart Failure
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 32
- 主要终点
- Impact of JVS-100 injection on Six Minute Walk Distance (6MWD) at 4 month follow-up
研究概览
简要总结
This is a randomized, double-blind, placebo controlled Phase II study is designed to assess the safety and efficacy of using JVS-100 to treat heart failure.
详细描述
90 subjects with ischemic cardiomyopathy will be randomized to receive a single dose of 15 or 30 mg of JVS-100 or matching placebo. Subjects will be randomized 1:1:1 to receive either placebo, 15 mg or 30 mg of JVS-100. Subjects will be monitored overnight for 18-24 hours post dose and have scheduled visits at 3 days post-injection for safety evaluations. All subjects will be scheduled for follow-up visits at approximately 30 days (1 month), 120 days (4 months), and 360 days (12 months) to assess safety and cardiac function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to sign informed consent
- •Greater than or equal to 18 years of age
- •Subjects with impaired 6 minute hall walk distance
- •Impaired quality of life as measured by Minnesota LWHF questionnaire
- •Ischemic cardiomyopathy without an acute coronary syndrome within the last 6 months
- •Residual well-demarcated region of LV systolic dysfunction defined as at least 3 consecutive segments of abnormal wall motion by echocardiography read at the echocardiography core laboratory
- •LVEF ≤40% measured by echocardiography read at the echocardiography core laboratory
- •Must meet wall thickness criteria
- •Subject has an implanted, functional AICD
- •Subjects with diabetes must have had an ophthalmologist exam within the last year showing no active proliferative retinopathy
- •Subject receiving stable optimal pharmacological therapy defined as:
- •ACE inhibitor and/or ARB, and Beta-blocker for 90 days with stable dose for 30 days unless contraindicated
- •Diuretic in subjects with evidence of fluid retention
- •ASA unless contraindicated
- •Statin unless contraindicated
- •Aldosterone antagonist per physician discretion
排除标准
- •Planned revascularization within 30 days following enrollment
- •Estimated Glomerular Filtration Rate < 30 ml/min*
- •Signs of acute heart failure within 24 hours of scheduled injection
- •History of aortic valve regurgitation classified as "moderate" or severe
- •Moderate/Severe aortic stenosis defined as AVA <1.5 cm2
- •Note: Patient should not be excluded if the patient's medical records document that within the last 6 months the patient has either:
- •no aortic stenosis
- •mild aortic stenosis
- •normal aortic valve
- •normal aortic pressure gradient
- •aortic pressure gradient < 20 mmHg
- •Presence of an artificial aortic valve
- •Subjects with aortic aneurysm >3.8 cm
- •Mitral regurgitation defined as "severe" measured by echocardiography at the clinical site.
- •Patients with planned mitral valve repair or replacement surgery
- •Any patient with a history of cancer will be excluded unless:
- •The cancer was limited to curable non-melanoma skin malignancies and/or
- •The cancer was removed by a successful tumor resection, with or without radiation or chemotherapy treatment, 5 years or more prior to enrollment in this study without recurrence
- •Subjects must have the following results on age appropriate cancer screenings:
- •Subjects age 50 or older have had a Fecal occult blood test (FOBT) or fecal immunochemical test (FIT) that was negative within the last year
- •Women age 30 or older have had a PAP test that was negative within the last 3 years
- •Women age 40 or older have had a mammogram that was negative within the last year
- •Men above age 45 have had a Prostate-Specific Antigen (PSA) blood test and digital rectal examination (DRE) that was negative within the last year
- •At the request of the site principal investigator, any subject with a non-negative result thought to be due to a non-cancer-related condition will be evaluated by the medical monitor for enrollment
- •Exclusion Criteria (ctd):
- •Subjects with persistent or chronic atrial fibrillation will be excluded unless:
- •A stable, regular heart rate is maintained with a biventricular pacemaker
- •A stable, regular heart rate is maintained with a univentricular pacemaker pacing less than or equal to 40% of the time
- •Subjects with Biventricular pacing device implant within the last 3 months OR previously implanted Biventricular pacing device with programming planned to be reoptimized following enrollment in this trial
- •Previous solid organ transplant
- •Subjects with greater than 40% univentricular RV Pacing
- •Subjects with uncontrolled diabetes defined as HbA1c >9.0%
- •Inability to complete 6 minute walk or treadmill exercise test
- •Participation in an experimental clinical trial within 30 days prior to enrollment
- •Any subject who has been enrolled in a gene or stem cell therapy cardiac trial within the last year
- •Life expectancy of less than 1 year
- •Positive pregnancy test (serum βHCG) in women of childbearing potential and/or unwillingness to use contraceptives or limit sexual activity as described in Section 8.2.1 below
- •Unwillingness of men capable of fathering a child to agree to use barrier contraception or limit sexual activity as described in Section 8.2.1 below
- •Subjects who are breast feeding
- •Subjects with a positive test results for hepatitis B/C and/or HIV
- •Total Serum Bilirubin >4.0 mg/dl
- •Aspartate aminotransferase (AST) > 120 IU/L
- •Alanine aminotransferase (ALT) > 135 IU/L
- •Alkaline phosphatase (ALP) >300 IU/L
- •Clinically significant elevations in PT or PTT relative to laboratory norms
- •Any subject with a known existing LV thrombus or has an LV thrombus detected during the screening period of this study.
- •Subjects with Rutherford class 5 or 6 critical limb ischemia
- •Subject with severe chronic obstructive pulmonary disease (COPD)
- •Any subject requiring home oxygen use
- •Subjects with a history of Systemic Lupus Erythematosus (SLE) flare
- 另有 2 项未显示
结局指标
主要结局
Impact of JVS-100 injection on Six Minute Walk Distance (6MWD) at 4 month follow-up
时间窗: 4 Months
To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on 6 minute walk distance compared to placebo at 4 months post-dosing
Impact of JVS-100 injection on Quality of Life at 4 month follow-up
时间窗: 4 months
To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on quality of life measured by the Minnesota Living with Heart Failure Questionnaire compared to placebo at 4 months post-dosing
次要结局
- Impact of JVS-100 Injection on Time to First Heart Failure Decompensation(Up to 12 months)
- Impact of JVS-100 Injection on Quality of Life(12 Months)
- Impact of JVS-100 Injection on number of adverse events(Up to 12 months)
- Impact of JVS-100 Injection on Major Adverse Cardiac Events(Up to 12 months)
- Impact of JVS-100 Injection on number of serious adverse events(Up to 12 months)
- Impact of JVS-100 Injection on NYHA class(4 months)
- Impact of JVS-100 Injection on LVEF(4 months)
研究者
研究点 (32)
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