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Nocturnal Blood Pressure - Central and Peripheral 24-h Blood Pressure in Chronic Kidney Disease.

Nocturnal Blood Pressure in Chronic Kidney Disease, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01951196
Acronym
NOSA
Enrollment
225
Registered
2013-09-26
Start date
2013-10-31
Completion date
2017-10-31
Last updated
2014-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Obstructive Sleep Apnea

Keywords

Chronic kidney disease, 24 hour blood pressure, central blood pressure, peripheral blood pressure, obstructive sleep apnea

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Erling Bjerregaard Pedersen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Patients, group 1: Inclusion Criteria: * eGFR 15-59 mL/min/1.73 m2 (estimated GFR) * 18-80 years * males and females

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
decrease in peripheral systolic blood pressure at night< 24 hoursThe difference in the decrease in systolic blood pressure at night by peripheral 24-h BP between patients with chronic kidney disease and healthy subjects.

Secondary

MeasureTime frameDescription
decrease in central systolic blood pressure at night< 24 hoursThe 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< 24 hoursThe 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.< 24 hours
U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel)24 hours24 hour urine sample.
PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin.< 1 hour

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026