Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome (a Double-blind Placebo-parallel Group Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in Heart Rate
研究概览
简要总结
Postural orthostatic tachycardia syndrome (POTS) occurs in approximately 500,000 Americans, but predominates in women with a 5:1 ratio. Patients with POTS experience debilitating tachycardia upon postural changes such as standing that impairs their quality of life. Tachycardia is clinically defined as a heart rate greater than 100 beats/min; and in POTS patients, the prolonged heart rate increase is greater than 30 beats/min or increases to 120 beats/min within the first ten minutes of a diagnostic tilt table test without postural hypotension. There are currently no effective treatment methods for POTS. However, several studies suggest Ivabradine could be a main treatment option for POTS because Ivabradine specifically inhibits the f-channels (If) within the sinoatrial (SA) node, which slows the heart rate. Currently in the US, Ivabradine is mainly prescribed to treat chronic heart failure. It is well tolerated in patients, but it is not commonly prescribed for POTS. It has been also used for treatment of inappropriate sinus tachycardia with good benefit. The hypothesis for this experiment is that Ivabradine will reduce tachycardia and improve functional status in patients with POTS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18-
- •Subjects must have POTS diagnosis (Hyperadrenergic Subtype with NE> 600pg/ml))
- •Subjects with no structural heart disease
- •Subject with no arrhythmias
- •Subjects with norepinephrine levels greater than 600 pg/ml
- •Subjects with normal CBC, Metabolic, and thyroid levels
排除标准
- •Thyroid or adrenal disorders
- •Drugs that interfere with Ivabradine (example: Cytochrome P450 drugs)
- •Presentation of peripheral edema and discolored toes with peripheral autonomic neuropathy. Symptoms include: legs (reduced hair growth, cramps), toes (blue color), legs/feet (wounds, ulcers that do not heal), and muscles (numbness, heaviness)
- •Subjects who have had a history of systemic illnesses (acute or chronic infectious); autoimmune/ inflammatory disease, cancer, COPD, anemia, diabetes, or psychiatric illness
- •Subjects with resting heart rate< 60beats/min, atrial fibrillation, advanced AV blocks, sinus disease, and acute decompensated heart failure and severe hepatic impairment.
- •Smokers or alcohol abuse
- •Pregnant or breastfeeding mothers
- •Woman of childbearing potential who are unwilling to use highly effective contraception during treatment and for an additional one month after discontinuing the study drug
研究组 & 干预措施
Placebo
Patient will consume one placebo pill twice a day for one month.
干预措施: Placebo (Drug)
Ivabradine
Patient will consume one dose of Ivabradine twice a day for one month.
干预措施: Ivabradine (Drug)
结局指标
主要结局
Change in Heart Rate
时间窗: Baseline and one month post-treatment
Orthostatic heart rate monitoring will be used to gauge heart rate changes.
次要结局
- Change in Quality of Life Via SF-36 Survey(Baseline and one month post-treatment)
研究者
Pam Taub, MD
Associate Professor of Medicine
University of California, San Diego