Natriruetic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluate urinary sodium
研究概览
简要总结
The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label.
详细描述
The study is carried out to evaluate primarily the difference in the activity of the renal transporter ENaC (through dosage of sodium) through its inhibition with a single dose of Amiloride in hypertensive patients characterized by the polymorphism of alpha Adducin rs496. It's also aimed to see the difference in potassium and the change in systolic and diastolic blood pressure after amiloride administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male patients aged 18-60 years;
- •naïve hypertensive patients: newly diagnosed, never previously treated for hypertension;
- •BMI<30 Kg/m2,
- •documented first degree essential arterial hypertension (mean of the last 3 consecutive systolic BP measurements must be >=140 mmHg or diastolic BP >=90 mmHg;
- •signature of the informed consent for participation in the study
- •patient who has already undergone genomic DNA sampling (accompanied by relative consent) and genotyped for the ADD1 rs4961 variant (GG, GT or TT).
排除标准
- •known causes of secondary hypertension;
- •severe or malignant hypertension; history of renal artery disease;
- •significant renal disease (creatinine clearance less than 60 ml/min);
- •hyperkalemia (Kpl > 6mEq/l) at enrollment visit;
- •hypercalcaemia (Ca pl > 2.6 mmol/l) at enrollment visit;
- •symptomatic hyperuricemia (> 7.5 mg/dl);
- •liver disease (transaminases greater than 3 times the normal value);
- •cardiac pathologies (myocardial infarction, atrial fibrillation, etc.);
- •diabetes (fasting blood sugar >125mg/dl);
- •in therapy with statins, NSAIDs, systemic steroids;
- •known hypersensitivity to Amiloride or to any of the excipients;
- •patients unable to express a valid consent -
研究组 & 干预措施
patients carrying the wild-type (GG) genotype of ADD1 rs4961
The protocol involves a test of oral administration of a single dose of Amiloride (5 or 10 mg based on body weight) to 20 patients carrying the wild-type (GG) genotype of ADD1 rs4961
干预措施: Amiloride (Drug)
patients carriers of variant T (GT or TT)
The test involves the administration of a single dose of 5 or 10 mg of Amiloride to 20 hypertensive carriers of the T variant (GT or TT)
干预措施: Amiloride (Drug)
结局指标
主要结局
Evaluate urinary sodium
时间窗: 3 hrs and 6 hrs
Evaluation of sodium levels after oral administration of Amiloride
次要结局
- Evaluate potassium levels(3 hrs and 6 hrs)
- Evaluation of systolic blood pressure(3 hrs and 6 hrs)
- Evaluation of diastolic blood pressure(3 hrs and 6 hrs)
研究者
Chiara Lanzani
medical doctor in nephrology unit, nephrologist
Ospedale San Raffaele