2024-517841-16-00招募中4 期
Evaluation of efficacy and tolerance of fludrocortisone (Flucortac) in the treatment of neurogenic orthostatic hypotension
H.A.C. Pharma7 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年10月29日最近更新:
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
- 7
- 主要终点
- Efficacy on the systolic and diastolic BP decrease when moving from supine and stand-up position
研究概览
简要总结
To evaluate the efficacy of a 4-week treatment with fludrocortisone (FLU) at stable dose on the decrease of systolic and diastolic blood pressure after 5 minutes of active orthostatism, in patients with neurogenic orthostatic hypotension
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age >18 years
- •Orthostatic hypotension (blodo pressure decrease >20 and/or 10mmHg on systolic and diastolic values within 3 minutes after standup, and symptomatic according to the Orthostatic Hypotension Questionnaire OHQ: score different than 0 in at least 1 of the 6 items
- •Patients suffering from a neurologic disease (Parkinson disease, multisystemic atrophy, Lewy bodies dementia, isolated progressive dysautonomia) or metabolic disease (diabetes, renal failure) known to be linked with an autonomous nervous system dysfunction and with NOH
- •Persistant and symptomatic NOH despite the use of non-medicinal measures (lower limbs contention) and medicinal products (midodrine)
排除标准
- •Age <18 years
- •Hypersensitivity to FLU or to one of its excipients
- •Medical history of documented cardiac failure
- •Medical history of left ventricular systolic dysfunction
- •Non-compensated hypokalaemia
- •Nocturnal or supine hypertension
- •Pregnant or breastfeeding patients
结局指标
主要结局
Efficacy on the systolic and diastolic BP decrease when moving from supine and stand-up position
Efficacy on the systolic and diastolic BP decrease when moving from supine and stand-up position
次要结局
- Evaluation of the symptoms related to NOH through the OHQ scale
- Evaluation of the quality of life through the SF36 scale
- Collection of clinical adverse events, biological and blood pressure anomalies
研究者
CERFON
Scientific
H.A.C. Pharma
研究点 (7)
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