Evaluation of Efficacy and Tolerance of Fludrocortisone (Flucortac) in the Treatment of Orthostatic Neurogenic Hypotension
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Systolic BP diminution
研究概览
简要总结
To evaluate the efficacy of a 4-week fludrocortisone (FLU) treatment on systolic blood pressure depression after 5 minutes of active orthostatism in patients with neurogenic orthostatic hypotension (HON) symptomatic, despite treatment with non-drug measures with or without midodrine.
详细描述
The objective of the study is to demonstrate the efficacy of FLU on systolic blood pressure depression in patients with neurogenic orthostatic hypotension. The study is randomised versus placebo.Each patient will be followed for a maximum of 5 months, with no more than 8 visits to the investigator (V0 at Day-7, V1 at D0, V2 at D7, V3 at D+14, V4 at D+21, V5 at D+ 28, V6 at D+56 and V7 only for patients on the FLU arm at D+140.
The presence of a comparator control group with placebo permits to evaluate the efficacy and the tolerance of FLU independently of the natural evolution of the pathology, in patients benefiting from a non-drug or possibly medicated treatment (midodrine) but insufficient.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of orthostatic hypotension (HO), ie a blood pressure drop> 20 and / or 10 mmHg within 3 minutes after active and symptomatic lifting
- •Patient suffering from a neurological disease
- •orthostatic neurogenic hypotension persistent and symptomatic despite non-drug measures
排除标准
- •Hypersensitivity to FLU or any of its excipients
- •non orthostatic neurogenic hypotension
- •History of proven heart failure
- •History of left ventricular systolic dysfunction
- •Uncompensated hypokalemia
- •Patient with poorly balanced Grade 3 hypertension
- •Pregnant patient at the time of inclusion
- •Nursing patient
研究组 & 干预措施
fludrocortisone
FLUCORTAC® 50 μg (tablet breackable). One tablet during the first week. Then 2 tablets during the second week. Then 3 tablets during the third week and finally 4 tablets during the 4th week. Maximum of 200μg/day.
干预措施: Fludrocortisone (Drug)
Placebo
placebo of flucortac and same diagram of administration
干预措施: Placebo (Other)
结局指标
主要结局
Systolic BP diminution
时间窗: 8 weeks
Systolic BP diminution when moving from supine to standing, measured with a semi-automatic blood pressure monitor - AP in upright position: the lowest value of the measurements obtained every minute, for 5 minutes after rising.
次要结局
未报告次要终点