NCT01961726Unknown1 期
A Phase I/II Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Retrograde Delivery to Cohorts of Adults With Ischemic Heart Failure
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 72
- 试验地点
- 8
- 主要终点
- Impact of JVS-100 delivery on 6 minute walk distance at 4 month follow-up
研究概览
简要总结
A phase I/II study to evaluate the safety and efficacy of JVS-100 administered by retrograde delivery to cohorts of adults with Ischemic Heart Failure.
详细描述
72 subjects with ischemic cardiomyopathy. The Phase I portion (n=12 subjects) will be open label. In the first cohort, six subjects will receive a single dose of 30 mg of JVS-100 with a minimum of 3 days between each enrollment. After seven days following the enrollment of the last patient of cohort 1, a safety assessment by the DSMC will be performed. Upon DSMC approval, the second cohort of six subjects will receive a single dose of 45 mg of JVS-100 with a minimum of 3 days between each enrollment. After seven days following the enrollment of the last patient of cohort 2, a safety assessment by the DSMC will be performed. Upon DSMC approval, up to 60 subjects will be randomized (1:1:1) to receive a single dose of 30 mg or 45 mg of JVS-100 or matching placebo.
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
- •Poor quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ)
- •Impaired 6 Minute Walk test
- •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 less than or equal to 40% measured by echocardiography read at the echocardiography core laboratory
- •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
- •Subject must not have a permanent device placed in the coronary sinus at the time of enrollment *As defined as no more than 50% change in dose
排除标准
- •Planned revascularization within 30 days following enrollment
- •Note: if an angiographic study has been performed within the last year and the subject is enrolled, the angiography study report should be included as part of the subject's file
- •Estimated Glomerular Filtration Rate < 30 ml/min*
- •Signs of acute heart failure within 24 hours of scheduled infusion
- •History of aortic valve regurgitation classified as "moderate-severe" or worse
- •Patients will be excluded who have:
- •Known prior trauma to the coronary sinus
- •In dwelling instrumentation that may hamper coronary venous catheterization, including a biventricular pacing coronary sinus lead
- •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 with persistent (per ACC/AHA/EEC guidelines)53, defined as recurrent AF episodes lasting longer than 7 days) 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
- •Inability to undergo 6 minute walk or treadmill exercise test
- •Previous solid organ transplant
- •Subjects with greater than 40% univentricular RV Pacing
- •Subjects with uncontrolled diabetes defined as HbA1c >10 %
- •Participation in an experimental clinical trial within 30 days prior to enrollment
- •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 will be excluded unless:
- •The subject is a carrier for hepatitis B/C but has never had an active flare
- •Subjects with a history of Systemic Lupus Erythematosus (SLE) flare
- •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 at day 0
- •Critical limb ischemia that limits the patients from completing 6 minute walk or treadmill testing
- •Subjects with severe chronic obstructive pulmonary disease (COPD)
- •Severe defined as having been hospitalized for COPD within the last 12 months
- •Any subject requiring home oxygen use for treatment of the symptoms of COPD
- •History of drug or alcohol abuse within the last year
- •A subject will be excluded if he/she is unfit for the trial based on the discretion of the site Principal Investigator
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: 30 mg dose of JVS-100 (Biological)
Placebo
Placebo Comparator
干预措施: 45 mg dose of JVS-100 (Biological)
30 mg dose of JVS-100
Experimental
干预措施: Placebo (Biological)
30 mg dose of JVS-100
Experimental
干预措施: 45 mg dose of JVS-100 (Biological)
45 mg dose of JVS-100
Experimental
干预措施: Placebo (Biological)
45 mg dose of JVS-100
Experimental
干预措施: 30 mg dose of JVS-100 (Biological)
结局指标
主要结局
Impact of JVS-100 delivery on 6 minute walk distance at 4 month follow-up
时间窗: 4 Months
To investigate the impact of single doses of JVS-100 (either 30 or 45 mg) delivered retrograde via the coronary sinus through the Oscor Venos Occlusion Balloon catheter on 6 minute walk distance compared to placebo at 4 months post dosing.
次要结局
- Impact of JVS-100 delivery on heart failure symptoms compared to placebo at 4 and/or 12 month follow-up(4 and/or 12 months)
研究者
研究点 (8)
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