Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percent drop in mean SBP at night time compared to mean SBP at day time
研究概览
简要总结
Hypertension (HTN) affects up to 75% of kidney transplant recipients and is associated with premature death. Nocturnal HTN is a common complication of ongoing essential HTN or a secondary cause of HTN. Both the non dipping of systolic blood pressure (SBP) at night time and the reverse dipping is associated with increased target organ damage and adverse cardiovascular outcomes and possibly allograft survival. Treatment of Nocturnal HTN is critical. Chronotherapy has been shown to be effective in halting progression in patients with diabetic nephropathy and chronic kidney disease. There is not enough data on prevalence and management of nocturnal HTN in transplant patients, which is the object of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal transplant more than 1 year ago and not on dialysis.
- •Age between 18 years to 70 years.
- •Known history of HTN on one or more anti-hypertensive medication.
- •Stable anti-hypertensive regimen for past 2 months
- •One of the anti-hypertensive regimen must include an ACE inhibitor, or an angiotensin receptor blocker, calcium channel blocker, alpha or beta blocker.
- •Stable immunosuppressive regimen with no dose changes in past 3 months.
- •No hospitalizations for previous 2 months
排除标准
- •Inability to consent
- •History of falls
- •Presence of AVF or AVG in both the arms
- •Inability to follow up in renal transplant clinic.
- •History of Atrial fibrillation.
- •Pregnant Women
- •Parkinson's Disease
- •Severe orthostatic Hypotension
- •Severe autonomic dysfunction
- •History of other transplanted organs
研究组 & 干预措施
chronotherapy
Patients identified with Nocturnal Hypertension, will have one of the blood pressure medications switched from daytime dosing to nighttime dosing
干预措施: Chronotherapy (Drug)
结局指标
主要结局
Percent drop in mean SBP at night time compared to mean SBP at day time
时间窗: 2 months
次要结局
- Urine Microalbumin to creatinine ratio(2 months)
- Change in Glomerular filtration rate as measured by MDRD equation.(2 months)
- 24 hour mean systolic Blood Pressure (SBP) Control(2 months)