Effect of Renin Inhibition on Cardiovascular Autonomic Nerve Function in Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure Before and After Treatment
研究概览
简要总结
This study will assess the effect of direct renin inhibition on nerve function in persons with diabetes using a double-blind, placebo-controlled randomized trial involving two treatment arms (i.e., [1] 30 participants enrolled and randomized to 300 mg of Aliskiren; [2] 30 participants enrolled and randomized to placebo).
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 (Participant, Investigator)
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
- •Individuals >18 years old with type 1 or type 2 diabetes mellitus.
排除标准
- •Individuals currently taking the maximum dose of an ACE inhibitor or an ARB.
- •Individuals with a history of a MI, percutaneous coronary interventions, coronary artery bypass graft (CABG) surgery, acute coronary syndromes, recent/on going atrial fibrillation, frequent atrial arrhythmias, frequent ventricular arrhythmias, or acute myocardial ischemia changes.
- •Individuals whose treatment dosage changes 2 months prior to the study for antihypertensive and antidiabetes medications, and the following medications that may affect the ANS: anti-tuberculosis drugs, nitrofurantoin, metronidazole, chloramphenicol, perhexiline maleate, amiodarone, clofibrate, tricyclic antidepressants, phenytoin, barbiturates, neuroleptic, antiparkinsonism drugs, and nitrated drugs.
- •Pregnant or lactating females.
- •Individuals with impaired renal function (i.e., creatinine >1.5 mg/dl), a history of dialysis, nephritic syndrome or renovascular hypertension.
- •Individuals with potassium levels within 0.5 mmol/L of the upper limit of normal (i.e., hyperkalemia).
研究组 & 干预措施
Aliskiren
Pill, 300 mg, once daily, for 6 weeks
干预措施: Aliskiren (Drug)
Aliskiren
Pill, 300 mg, once daily, for 6 weeks
干预措施: Placebo (Other)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Systolic Blood Pressure Before and After Treatment
时间窗: baseline and 6 weeks
Systolic blood pressure at baseline and follow-up
Diastolic Blood Pressure Before and After Treatment
时间窗: baseline and 6 weeks
Diastolic blood pressure at baseline and follow-up.
Serum Renin Level Before and After Treatment
时间窗: baseline and 6 weeks
Serum renin level at baseline and follow-up
Expiration/Inspiration Ratio Before and After Treatment
时间窗: baseline and 6 weeks
Expiration/inspiration ratio at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis \[i.e. mean circular resultant (MCR)\] and by the expiration/inspiration (E/I) ratio of the first six breath cycles.
Mean Circular Resultant Before and After Treatment
时间窗: baseline and 6 weeks
Mean circular resultant at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis \[i.e. mean circular resultant (MCR)\] and by the expiration/inspiration (E/I) ratio of the first six breath cycles. With regard to the MCR, the length of the vector mean is proportional to the degree of HRV. Weinberg and Pfeifer first introduced the assessment of HRV via determination of the MCR in a paper in Biometrics 1984:40:855-861. Low HRV is considered to be less favorable.
次要结局
未报告次要终点