Nocturnal Blood Pressure - Central and Peripheral 24-h Blood Pressure in Chronic Kidney Disease. (NOSA)
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|ClinicalTrials.gov Identifier: NCT01951196|
Recruitment Status : Unknown
Verified October 2014 by Erling Bjerregaard Pedersen, Regional Hospital Holstebro.
Recruitment status was: Active, not recruiting
First Posted : September 26, 2013
Last Update Posted : October 9, 2014
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.
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.
|Condition or disease|
|Chronic Kidney Disease Obstructive Sleep Apnea|
|Study Type :||Observational|
|Estimated Enrollment :||225 participants|
|Observational Model:||Case Control|
|Official Title:||Nocturnal Blood Pressure in Chronic Kidney Disease, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure.|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||October 2017|
Chronic kidney disease, CKD III+IV
150 patients with Chronic kidney disease, CKD stage III+IV.
75 healthy subjects.
- decrease in peripheral systolic blood pressure at night [ Time Frame: < 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.
- decrease in central systolic blood pressure at night [ Time Frame: < 24 hours ]The difference in the decrease in systolic BP at night by central 24-h BP between patients with chronic kidney disease and healthy subjects.
- difference in peripheral and central systolic and diastolic blood pressure throughout the day, during the daytime and during nighttime [ Time Frame: < 24 hours ]The difference in systolic blood pressure and diastolic blood pressure throughout the day, during the daytime and during nighttime between measurements with peripheral 24-hour monitoring and central 24 hour monitoring in both patients with chronic kidney disease and healthy subjects.
- 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. [ Time Frame: < 24 hours ]
- U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel) [ Time Frame: 24 hours ]24 hour urine sample.
- PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin. [ Time Frame: < 1 hour ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951196
|Department of Medical Research and Medicine, Holstebro Regional Hospital|
|Holstebro, Denmark, 7500|