The Effect of Capsaicin-Phenylephrine-Caffeine Formulation on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test
研究概览
简要总结
Syncope is defined as transient loss of consciousness associated with inability to maintain postural tone with rapid and spontaneous recovery. The purpose of this study is to assess the effects of sublingual administration of a new medication called CPC on tilt-induced syncope in patients with a history of vasovagal syncope (VVS) or near syncope. 140 participants will be randomized at the University of Wisconsin - Madison. Each participant will be in the study for 1 day.
详细描述
Vasovagal syncope (VVS) is the most common type of syncope. The mechanism is reflex-mediated triggered by various afferent input to the brain. The event is usually preceded by diaphoresis, warmth, nausea, and pallor, and is followed by fatigue. While several drugs are indicated in the treatment of VVS, to our knowledge, there is no current treatment of an impending syncopal attack. In the present study, the investigators hypothesized that a single administration of sublingual CPC preparation during the prodromal phase would abort tilt-induced syncope or near syncope with SBP less than or equal to 70 mmHg in patients with a history of VVS. Patients with an established diagnosis of typical VVS or near syncope will be randomized to receive CPC or placebo in 1:1 ratio. Drug or placebo will be administered at the onset of prodromes during tilt table testing. In addition to the primary endpoint (syncope or near syncope with SBP less than or equal to 70 mmHg), the investigators will be assessing the effects of the drug on time to event, incidence of asystole (> 3 sec), and fatigue after syncope.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomized 1:1 to CPC or placebo
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of typical vasovagal syncope or near syncope
- •Age 18-50 years
排除标准
- •Systolic BP >130 mmHg
- •History of hypertension or cardiac arrhythmias
- •History of cardiovascular disease or cerebral ischemic events
- •Allergic reaction to any of the drug components
- •Contraindication to tilt testing
- •Any physical or psychological symptom, based on the clinical judgment of the investigators that would make a participant unsuitable for the study
- •Any use of a medication(s) based on the clinical judgment of the investigators that would make a participant unsuitable for the study (e.g. fludrocortisone, theophylline, prazosin, doxazosin, terazosin, MAO-inhibitors, pseudoephedrine, decongestant and PDE5 inhibitors).
- •Unwilling to discontinue Midodrine or beta-blocker therapy 48 hours before tilt table testing.
- •Women who are pregnant (confirmed with pregnancy test on day of study) or lactating.
研究组 & 干预措施
CPC Adminstration
Single dose of CPC will be given during tilt table test
干预措施: CPC - Capsaicin, Phenylephrine, Caffeine (Drug)
CPC Adminstration
Single dose of CPC will be given during tilt table test
干预措施: Tilt Table Test (Diagnostic Test)
Placebo Adminstration
Single dose of Placebo will be given during tilt table test
干预措施: Tilt Table Test (Diagnostic Test)
Placebo Adminstration
Single dose of Placebo will be given during tilt table test
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test
时间窗: During tilt table testing (up to approximately 35 minutes)
Hypotensive syncope is defined as transient loss of consciousness associated with SBP less than or equal to 90 mmHg. Near syncope is defined as sensation of "near fainting" while still being responsive to verbal commands. Near syncope will be used as a primary endpoint only when it is associated with a SBP less than or equal to 70 mmHg.
Time to Syncope or Near-syncope After CPC or Placebo Administration
时间窗: During tilt table testing (up to approximately 35 minutes)
Time in seconds from CPC or Placebo administration to syncope or near syncope in patients who had an event
次要结局
- Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms(During tilt table testing (up to approximately 35 minutes))
- Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing(Up to 8 hours after tilt table testing (up to approximately 8 hours and 35 minutes))