Nocturnal Blood Pressure in Chronic Kidney Disease, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- decrease in peripheral systolic blood pressure at night
研究概览
简要总结
A new study have shown that high nighttime blood pressure (BP) and/or non-dipping (lack of fall in blood pressure during nighttime) is a strong predictor for the risk of cardiovascular disease and mortality in patients with hypertension. Three factors seem to affect the night time blood pressure: chronic kidney disease, obstructive sleep apnea (OSA) or the way ambulatory blood pressure is monitored.
The aim of this study is to analyse the importance of these three factors on nighttime bloodpressure.
Hypothesis:
Central 24 hour blood pressure monitoring provides another measure of daily fluctuations in blood pressure than peripheral 24 hour blood pressure monitoring, because measurement is painless and does not interfere with activities during the daytime or night-time sleep
In chronic kidney disease and OSA the decrease in nocturnal BP is lower than in healthy subjects.
In chronic kidney disease the decrease in the nocturnal BP is inversely correlated to the severity of OSA, the severity of kidney disease, and blood pressure during daytime.
详细描述
150 patients with chronic kidney disease (CKD III-IV) and 75 healthy subject is examined with both central and peripheral 24 hours blood pressure monitoring, 1 night home polygraphy to determine whether the subject has obstructive sleep apnea, and if so the degree (AHI), blood- and urine samples to determine levels of u-AQP2 og u-ENaCɣ, PRC, p-AngII, p-Aldosterone, p-Avp og p-Endothelin.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •eGFR 15-59 mL/min/1.73 m2 (estimated GFR)
- •18-80 years
- •males and females
排除标准
- •lack of desire to participate
- •treatment for OSA
- •malignant disease
- •Abuse of drugs or alcohol
- •pregnant and lactating
- •incompensated heart failure
- •atrial fibrillation
- •liver disease (ALAT> 200)
- •Severe chronic obstructive lung disease (forced expiratory volume in 1 second <50% predicted)
- •Healthy Subjects:
- •inclusion criteria
- •Healthy volunteers men and women
- •age 40 - 80 years
- •BMI within the normal range, ie. between 18.5 to 25.0 kg/m2
- •exclusion Criteria
- •Arterial hypertension, ie. ambulatory blood pressure> 130 mmHg systolic and / or 80 mmHg diastolic.
- •a history or clinical signs of cardial, pulmonary, hepato, renal, endocrine, cerebral or neoplastic disorders
- •Alcohol abuse, ie. > 14 drinks / week for women and> 21/uge for men
- •Substance abuse
- •Daily medicine intake/ treatment apart from oral contraceptives
- •Pregnancy or breastfeeding
- •Lack of desire to participate
- •Clinically significant, discrepant results of blood or urine sample at inclusion study (ie B-hemoglobin and B-White blood cell count, p-Sodium, p-Potassium, p-creatinine, p-ALAT, p-bilirubin , p-alkaline phosphatase, p-cholesterol, p-albumin or b-glucose and urine for hematuria, albuminuria or glucosuria)
- •Clinically significant differences in the electrocardiogram
- •Blood Donation for the past month preceding the day on the first attempt sequence.
结局指标
主要结局
decrease in peripheral systolic blood pressure at night
时间窗: < 24 hours
The difference in the decrease in systolic blood pressure at night by peripheral 24-h BP between patients with chronic kidney disease and healthy subjects.
次要结局
- decrease in central systolic blood pressure at night(< 24 hours)
- difference in peripheral and central systolic and diastolic blood pressure throughout the day, during the daytime and during nighttime(< 24 hours)
- The correlation between the decrease in nighttime blood pressure on the one hand and severity of OSA, severity of kidney disease and blood pressure during the daytime on the other.(< 24 hours)
- U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel)(24 hours)
- PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin.(< 1 hour)
研究者
Erling Bjerregaard Pedersen
professor
Regional Hospital Holstebro