Effect of Oral Propranolol on mRNA Expression in Symptomatice Caavernous Malformation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- To measure effects of low-dose oral propranolol on global messenger RNA (mRNA) and microRNA (miRNA) expression in the blood and tissue of patients with CCM
研究概览
简要总结
This is a single center, randomized, trial that will enroll twenty (n=20) patients with a diagnosis of symptomatic cavernous malformations who are planned candidates for surgical resection by one of the investigators, and who meet all of the inclusion and exclusion criteria. Patients will be randomized into two groups: A Treatment group of ten (n=10) patients that will receive oral propranolol at a dose of 60mg per day (one 60mg ER capsule per day) for 7- to 10-days prior to surgery plus their usual medications, and a Control group of 10 (n=10) patients will receive only their routine medications. Currently, the only active treatment alternative for symptomatic cerebral cavernous malformations is surgery.
A control group is required to allow for a semi-quantitative comparison with mRNA and miRNA levels in the treatment group.
详细描述
This is a single center, randomized, trial that will enroll twenty (n=20) patients with a diagnosis of symptomatic cavernous malformations who are planned candidates for surgical resection by one of the investigators, and who meet all of the inclusion and exclusion criteria. Patients will be randomized into two groups: A Treatment group of ten (n=10) patients that will receive oral propranolol at a dose of 60mg per day (one 60mg ER capsule per day) for 7- to 10-days prior to surgery plus their usual medications, and a Control group of 10 (n=10) patients will receive only their routine medications. Currently, the only active treatment alternative for symptomatic cerebral cavernous malformations is surgery.
A control group is required to allow for a semi-quantitative comparison with mRNA and miRNA levels in the treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Subject is at least 18-years of age.
- •Clinical and imaging diagnosis of a symptomatic Isolated cavernous malformation or Familial cavernous malformation
- •MRI Imaging Grade Type I or Type II (see Table 1)
- •Patient is considered a candidate for surgical resection of their cavernous malformation
- •Written and informed consent obtained prior to the study enrollment.
- •Negative pregnancy test at time of enrollment for women of child-bearing potential.
- •Heart rate greater than 50 beats per minute
- •Systolic blood pressure > 90 mmHg
排除标准
- •Subject is less than 18-years of age.
- •History of allergy to propranolol or other beta blockers.
- •Patient is already taking another beta blocker for cardiac indications.
- •History of asthma presently requiring any active treatment (oral medications or inhalers).
- •History of cardiac dysfunction (as defined by the New York Heart Association Functional Classification grade II, III or IV).
- •Heart rate < 50 beats per minute
- •Systolic blood pressure < 90 mmHg
- •History of diabetes and currently on any anti-hyperglycemic medication.
- •Pregnant and lactating women.
研究组 & 干预措施
treatment group
A Treatment group of ten (n=10) patients that will receive oral propranolol at a dose of 60mg per day (one 60mg ER capsule per day) for 7- to 10-days prior to surgery plus their usual medications.
干预措施: Propranolol (Drug)
treatment group
A Treatment group of ten (n=10) patients that will receive oral propranolol at a dose of 60mg per day (one 60mg ER capsule per day) for 7- to 10-days prior to surgery plus their usual medications.
干预措施: DNA and RNA Analysis (Genetic)
Control Group
A control group of 10 (n=10) patients will receive only their routine medications (no propranolol) during the (-7 to -10 days) preoperative period. A control group (n=10) is required to allow for a semi-quantitative comparison with mRNA and miRNA levels in the treatment group.
干预措施: DNA and RNA Analysis (Genetic)
结局指标
主要结局
To measure effects of low-dose oral propranolol on global messenger RNA (mRNA) and microRNA (miRNA) expression in the blood and tissue of patients with CCM
时间窗: -7 to -10 days until surgery
compare changes noted in mRNA and miRNA in blood and CCM tissue samples of patients who do and do not receive propranolol preoperatively for CCM
次要结局
- Record adverse event (tolerance to) related to low-dose oral propranolol (60mg ER once daily)(-7 to -10 days until surgery)
- To correlate treatment response to propranolol with the underlying established mutations in cerebral cavernous malformation (CCM) genes.(-7 to -10 days until surgery)
研究者
Lori Wood
Research Operations Manager
St. Joseph's Hospital and Medical Center, Phoenix