EUCTR2020-001014-37-IT进行中(未招募)1 期
Pharmacogenetics of hypertension: randomized monocentric study in patients with essential hypertension and treated with Spironolactone or Torasemide - Pharmacogenetics of hypertension: study with Spironolactone or Torasemide
OSPEDALE SAN RAFFAELE0 个研究点目标入组 144 人开始时间: 2020年10月21日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a. male patients aged 25-65 years and female patients aged 45-65 years in menopause
- •b. naïve hypertensive patients (newly diagnosed, never previously treated) or in therapy with a single anti-hypertensive drug
- •c. documented hypertension of grade I or II (according to ESH 2013 guidelines, in the untreated patient or despite the therapy).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 144
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a. known causes of secondary hypertension
- •b. stage II hypertension (SBP = 180 and DBP = 110 mmHg;
- •c. history of renal artery stenosis
- •d. significant kidney disease (eGFR-CK-EPI less than 60 ml/min)
- •e. refractory hypokalaemia or hyponatraemia (plasma Na < 126 mEq/L)
- •f. hyperkalaemia (plasma K > 5.5 mEq/L)
- •g. hypercalcaemia
- •h. symptomatic hyperuricemia
- •i. liver disease (transaminases greater than 3 times the maximum laboratory value)
- •j. cardiac pathologies (previous myocardial infarction, ongoing atrial fibrillation, etc.)
- •k. diabetes (fasting blood sugar > 126mg/dL)
- •l. treatment with statins in progress
- •m. obesity (BMI > 30 kg/m2)
- •n. known hypersensitivity to the study drugs (Spironolactone or Torasemide) or to any of the excipients
研究者
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