跳至主要内容
临床试验/EUCTR2020-001014-37-IT
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

发起方
OSPEDALE SAN RAFFAELE

相似试验