Trials / Unknown
UnknownNCT02078765
Nocturnal Blood Pressure and Hypertension - Central and Peripheral 24-h Blood Pressure.
Nocturnal Blood Pressure in Hypertension, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- Erling Bjerregaard Pedersen · Academic / Other
- Sex
- All
- Age
- 55 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
A new study have shown that high night time blood pressure (BP) and/or non-dipping (lack of fall in BP during night time) is a strong predictor for the risk of cardiovascular disease and mortality in patients with hypertension. Three factors seem to affect the night time BP: chronic kidney disease, obstructive sleep apnea (OSA) and the way ambulatory blood pressure is monitored. Hypothesis: Central 24-h blood pressure monitoring is a better way of monitoring blood pressure than conventional peripheral monitoring. In hypertension, chronic kidney disease and obstructive sleep apnea (OSA) the night time blood pressure is elevated, and is OSA the elevation is correlated to the severity of OSA. In OSA the kidneys handling of salt and water is disturbed. In OSA there is disturbances in hormonal balance.
Detailed description
75 patients with hypertension and chronic kidney disease (CKD I-II) and 75 healthy subjects 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 (OSA), and if so the degree (apnea hypopnea index, AHI), blood and urine samples to determine levels of urine aquaporine2 (u-AQP2), urine endothelial sodium channel (u-EnaC), plasma renin concentration (PRC), plasma angiotensin II (p-AngII), plasma aldosterone (p-aldosterone), plasma vasopressin (p-AVP) and plasma endothelin (p-endothelin). Hypothesis: Central 24-h BP monitoring provides another measure of daily fluctuations in blood pressure than peripheral 24-h BP monitoring, because this measurement is painless and does not interfere with activities in the daytime or night-time sleep. In hypertension, chronic kidney disease and OSA the decease in nocturnal BP is lower than i healthy subjects. In OSA the decrease in the nocturnal BP is inversely correlated with the severity of OSA. In OSA is the renal tubular absorption of water and sodium abnormal with increased tubular absorption of water with AQP2 and of sodium by ENAC. In OSA, there is increased activity of the renin-angiotensin-aldosterone system, increased endothelin in plasma and increased vasopressin in plasma.
Conditions
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2015-12-01
- Completion
- 2017-12-01
- First posted
- 2014-03-05
- Last updated
- 2014-10-09
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT02078765. Inclusion in this directory is not an endorsement.