ACTRN12612000157875已完成2 期
Effects of L-DOPS on Noradrenaline Responses to Head-up Tilt in patients with Low- and Normal- Supine Blood Pressure Variant of Orthostatic Intolerance.
BakerIDI Heart and Diabetes Institute0 个研究点目标入组 23 人开始时间: 2012年2月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- Female
入选标准
- •Participants with Orthostatic Intolerance
- •1.Age 18-50
- •2.Clinical disorder of orthostatic intolerance in association with syncope or recurrent presyncope.
- •a.An underlying medical condition causing these symptoms has been excluded, in particular structural heart disease, Addison’s disease and hypothyroidism.
- •b.Symptoms will have been present and occurring at least weekly for > or = 6 months. Symptoms include lightheadedness, weakness, blurred vision, syncope or presyncope.
- •3.Clinical Phenotype consistent with either Low- or Normal- Supine BP Vasovagal syncope;
- •a.Low- Supine Blood Pressure is defined as a typical (two or more BP readings by a medical practitioner) supine blood pressure of < or= 100 mmHg
- •b.Normal-Supine Blood Pressure is defined as a typical supine blood pressure of > or = 110 and < or = 140 mmHg
- •Healthy Control Participants for Basline comparison only ( no drug phase):
- •Aged between 18- 50 years.
- •No history of fainting or symptoms such as light-headedness, blurred vision, nausea or palpitations in association with standing.
排除标准
- •Participants with Orthostatic Intolerance:
- •1.Age <18 or > 50
- •2.Pregnant or Breastfeeding women
- •3.Women of childbearing potential who are not using medically accepted contraception;
- •Reproductive potential: Female subjects should be either postmenopausal
- •(amenorrhea for at least 12 consecutive months), surgically sterile,
- •or women of child-bearing potential (WOCP) who are using or agree to use
- •acceptable methods of contraception. Acceptable contraceptives include
- •intrauterine devices (IUDs), hormonal contraceptives (oral, depot, patch or
- •injectable) and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
- •4.Sexually active males whose partner is a WOCP and who do not agree to use
- •condoms for the duration of the study and for 30 days after the last dose;
- •5.Inability to withhold pressor medications for the duration of the study. Pressor medications, (eg Fludrocortisone, Midodrine, Dihydroergotamine, Pseudoephedrine, Licorice Extract, Butcher’s Broom, Cold and Flu remedies, Diet pills, NSAIDs, pyridostigmine) must be ceased for 2 weeks prior to the commencement of the study and withheld for the entire duration of the study.
- •6.Antidepressant medications including: tricyclics and tetracyclic antidepressants, SSRI/ SNRI/ NRI’s, MAO inhibitors;
- •7. Medications known to lower blood pressure that cannot be withheld for the duration of the study, eg beta -blockers;
- •8.Presence of structural heart disease – including ischaemic heart disease.
- •9.Hypertension (supine SBP > or =140 mmHg)
- •10.Diabetes
- •11.Gastrointestinal illness that may impair absorption of the study drug.
- •12.Known or suspected hypersensitivity to the study medication or any of its ingredients;
- •13.In the investigator’s opinion, have clinically significant abnormalities on clinical examination or laboratory testing;
- •Healthy Control Participants:
- •Age<18 or >50 years
- •Necessary Medication other than the oral controaceptive pill
- •Pregnant or Breastfeeding
研究者
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