Effect of Renal Denervation on NO-mediated Regulation of Salt- and Water Excretion, Vasoactive Hormones and Tubular Transport Proteins in Patients With Resistant Hypertension
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fractional excretion of sodium after acute L-NMMA treatment
研究概览
简要总结
Catheter based renal denervation (CRD) in humans represents a promising new treatment of resistant hypertension. CRD is currently investigated as a treatment option in patients with resistant hypertension defined as at least 3 antihypertensive drugs (including a diuretic) in a randomized, sham-controlled, multicenter trial in Denmark (ReSet). In ReSet, patients are randomized to either CRD or a sham procedure with 6 months follow up. The mechanisms by which CRD reduce blood pressure are only partly understood and the interaction between renal sympathetic nerves and nitric oxide (NO) has not been investigated in humans.
To Study the interaction between NO and renal sympathetic nerves, we designed the present substudy, where the effects of NO-inhibition on renal, hemodynamic and hormonal variables are studied before and after CRD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-70 years
- •Stable antihypertensive treatment for 1-month with at least 3 antihypertensive drugs including a diuretic
- •Day-time ambulatory blood pressure > 145/75 mmHg
排除标准
- •Non compliance
- •Pregnancy/no-anticonception in fertile women
- •Radiocontrast allergy
- •Malignancy
- •Congestive heart failure (EF < 50)
- •eGFR < 45
- •Unstable angina pectoris
- •Recent myocardial infarction or PCI (< 6 mdr)
- •Secondary hypertension
- •Renal artery stenosis or multiple renal arteries on CT
- •Claudication
研究组 & 干预措施
Renal denervation
Patient group randomized to renal denervation
干预措施: NG-monomethyl-L-arginine (L-NMMA) (Drug)
Sham
Patients randomized to sham procedure
干预措施: NG-monomethyl-L-arginine (L-NMMA) (Drug)
结局指标
主要结局
Fractional excretion of sodium after acute L-NMMA treatment
时间窗: 1 month before and after CRD
次要结局
- Glomerular filtration rate (GFR) before and after L-NMMA treatment(1 month before and after CRD)
研究者
Erling Bjerregaard Pedersen
Professor, MD, Dr.Sci.
Regional Hospital Holstebro