Cardiorenal Effecs of Losartan in Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 入组人数
- 740
- 试验地点
- 1
- 主要终点
- Occurrence of composite primary endpoint:
研究概览
简要总结
The influence of Losartan to cardiovascular and renal outcomes in patients after renal transplatation.
详细描述
The benefits of cardio and nephroprotective properties of treatment with drugs blocking the renin angiotensin aldosterone system in the general population has already been shown. There are no data on the cardiac and renal effects of this type of treatment in patients after renal transplantation.
Therefore, the observational, case-control study was designed in a population of kidney transplant recipients.
The study group consists of patients treated with antihypertensive drugs including Losartan at a minimum dose of 50mg.
The control group consists of patients treated with antihypertensive drugs, without the renin angiotensin aldosterone system blockade.
Blood pressure will be controlled in accordance with the current recommendations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •740 patients, either sex, either non-diabetic or diabetic who underwent the kidney transplantation and who:
- •Are at least three months post-transplantation
- •Have hypertension.
- •Have an estimated glomerular filtration rate greater than or equal to 30 ml/min/1.73 m2
排除标准
- •Pregnant or the possibility of becoming so and breast feeding.
- •Angioedema from an Angiotensin Converting Enzyme (ACE) inhibitor or Angiotensin Receptor Blocker (ARB) in the history.
- •Serum potassium greater than 5.5 mmol/l on two or more occasions in the preceding three months.
- •Graft artery stenosis (i.e. psv of more than 200 cm/s in doppler usg)
- •Left ventricular dysfunction that requires an ACE inhibitor or an ARB
- •New immunosuppressive agent was started or previous immunosuppressant stopped in the three months prior to study entry or plan to switch immunosuppressive agents within next three months.
- •Currently on four or more blood pressure pills and have an average blood pressure over three visits greater than 150/
- •Currently on an ACE-inhibitor or an ARB or treatment with an ACE inhibitor or ARB after kidney transplantation lasted more than 3 months.
- •Had an acute coronary syndrome, episode of malignant hypertension, stroke or transient ischaemic attack in the three months prior to study entry.
研究组 & 干预措施
Study group
Hypotensive treatment including Losartan
干预措施: Losartan (Drug)
结局指标
主要结局
Occurrence of composite primary endpoint:
时间窗: Up to 5 years
Cardiovascular (CV) death and Resuscitated sudden death and Non-fatal myocardial infarction (MI) and Non-fatal stroke and Unplanned hospitalization for heart failure or unstable angina and Onset of end-stage renal disease (ESRD) and Doubling of baseline serum creatinine concentration, sustained for at least one month.
次要结局
- 15-F2t-isoprostanes (isoprostanes) urine excretion(after 6 months)
- Occurrence of cardiovascular complications(Up to 5 years)
- Decline in estimated glomerular filtration rate (eGFR)(Up to 5 years)
- Urine albumine concentration(after 6 months)
- N-acetyl-β-D-glucosaminidase (NAG) urine excretion(after 6 months)
- Occurrence of renal complications(Up to 5 years)
研究者
Leszek Tylicki
Professor
Medical University of Gdansk