A Prospective, Randomized, Double-blind, Double-dummy, Forced Titration, Parallel Group Comparison, Multicenter Trial to Compare the Effects of Either Telmisartan (40-80 mg p.o. Once Daily) or Ramipril (5-10 mg p.o. Once Daily) on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 10
- 主要终点
- Change from baseline of renal plasma flow (RPF) in response to L-NMMA infusion at the end of treatment.
研究概览
简要总结
The primary objective is to evaluate the effect of 9 weeks treatment with either telmisartan or ramipril on NO bioavailability in the renal vasculature, measured as renal plasma flow (RPF) in response to NG-monomethyl-L-arginine (LNMMA) infusion.
详细描述
This study was designed as a randomised, double-blind, double-dummy, parallel group in hypertensive patients with type 2 diabetes and normo- or microalbuminuria over a treatment period of 9 weeks.
After a 4 week Run-in period, patients will be randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Ramipril 5 - 10 mg. The treatment regimen is a forced titration with the lower dose given for 3 weeks and the higher dose given for the rest of the treatment period summing up to 9 weeks of treatment. During the treatment period, 3 visits to the investigator will be scheduled in order to control blood pressure, renal function parameters and safety. In addition, parameters of endothelial function in the renal vasculature, based on a nephrological clearance investigation and a provocation with L-NMMA will be measured at baseline and after 9 weeks of treatment.
Study Hypothesis:
Due to the exploratory nature of the trial, the primary objective to evaluate the effect on RPF in response to L-NMMA infusion at baseline and after 9 weeks of therapy with either telmisartan 80 mg or ramipril 10 mg was not planned to be addressed by a test of prespecified hypotheses.
Comparison(s):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertensive patients aged 30-80 years with type 2 diabetes, normo- or microalbuminuria, GFR > 80 mL/min (Cockroft-Gault)
排除标准
- 未提供
结局指标
主要结局
Change from baseline of renal plasma flow (RPF) in response to L-NMMA infusion at the end of treatment.
时间窗: 9 weeks
次要结局
- Change from baseline of GFR in response to L-arginine infusion at the end of treatment(9 weeks)
- Change from baseline of the pre-L-NMMA RPF at the end of treatment(9 weeks)
- Change from baseline of the pre-L-NMMA GFR at the end of treatment(9 weeks)
- Change from baseline of RPF in response to L-arginine infusion at the end of treatment.(9 weeks)
- Change from baseline of mean arterial pressure (MAP) and pulse rate (PR) in response to L-NMMA infusion at the end of treatment.(9 weeks)
- Change from baseline of MAP and PR in response to L-arginine infusion at the end of treatment.(9 weeks)
- Changes from screening in physical examination at the end of the study(- 4 weeks and 9 weeks)
- Changes from screening in ECG at the end of the study(- 4 weeks and 9 weeks)
- Change from baseline of glomerular filtration rate (GFR) in response to L-NMMA infusion at the end of treatment(9 weeks)
- Change from baseline of renal vascular resistance (RVR) in response to L-NMMA infusion at the end of treatment.(9 weeks)
- Change from baseline of FF in response to L-arginine infusion at the end of treatment.(9 weeks)
- Change from baseline of the laboratory parameters angiotensin II (ANG II), aldosterone, asymmetrical dimethylarginine (ADMA), L-arginine, urinary nitrate/nitrite (UNOx), and urinary albumin excretion at the end of treatment(9 weeks)
- Change from baseline of the pre-L-NMMA RVR at the end of treatment.(9 weeks)
- Change from baseline of the urinary excretion parameters creatinine, sodium, potassium, and urea at the end of treatment.(9 weeks)
- Change from baseline of filtration fraction (FF) in response to L-NMMA infusion at the end of treatment.(9 weeks)
- Change from baseline of RVR in response to L-arginine infusion at the end of treatment.(9 weeks)
- Change from baseline of the pre-L-NMMA FF at the end of treatment.(9 weeks)
- Change from baseline of central blood pressure and augmentation index (by pulse wave analysis) at the end of treatment.(9 weeks)
- Change from baseline of FF in response to Vitamin C infusion at the end of treatment.(9 weeks)
- Change from baseline of RVR in response to Vitamin C infusion at the end of treatment.(9 weeks)
- Change from baseline of MAP and PR in response to Vitamin C infusion at the end of treatment.(9 weeks)
- Incidence of adverse events(week -2 and 9 weeks)
- Changes from base line in routine laboratory data at the end of the study(9 weeks)
- Changes in vital signs(9 weeks)
- Blood pressure response and control at the end of treatment(9 weeks)
- Change from baseline of RPF in response to Vitamin C infusion at the end of treatment(9 weeks)
- Change from baseline of GFR in response to Vitamin C infusion at the end of treatment(9 weeks)