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临床试验/NCT01750294
NCT01750294已完成4 期

A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD

Indiana University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2012年8月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
14
试验地点
1
主要终点
Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks

研究概览

简要总结

It is estimated that in the United States there are approximately 8 million individuals with moderate to severe chronic kidney disease (CKD), not on dialysis. Volume expansion plays an important role in the pathogenesis of hypertension in patients with CKD. For this pilot study, the investigators hypothesize that administration of chlorthalidone among patients with moderate to severe CKD will improve blood pressure (BP).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age greater than 18 years.
  • •Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 but ≥20 mL/min/1.73m
  • •Poorly controlled blood pressure by 24-hour ambulatory blood pressure (BP) monitoring.
  • •Treated hypertension: use of at least one antihypertensive drug. One of the drugs should be either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). If these are contraindicated then use of a beta-blocker is required.

排除标准

  • •Use of thiazide or thiazide-like drugs in the previous 3 months.
  • •Use of furosemide in a dose >200 mg/d.
  • •Ambulatory BP of either ≥160 systolic or ≥100 mmHg by 24-hour ambulatory BP monitoring.
  • •Expected to receive renal replacement therapy within the next 3 months.
  • •Vascular event such as myocardial infarction, heart failure hospitalization, or stroke within 3 months prior to randomization.
  • •Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception (oral contraceptives. condoms and diaphragms will be considered reliable).
  • •Known hypersensitivity to thiazide or sulfa drugs.
  • •Organ transplant recipient or therapy with immunosuppressive agents. Nasal or inhaled corticosteroids will be permitted.

结局指标

主要结局

Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks

时间窗: Baseline and 12 weeks after intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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