Overview

This trial is active, not recruiting.

Conditions chronic kidney disease, obstructive sleep apnea
Sponsor Erling Bjerregaard Pedersen
Start date October 2013
End date December 2015
Trial size 225 participants
Trial identifier NCT01951196, BGH-1-2013, M-2013-224-13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Arm
150 patients with Chronic kidney disease, CKD stage III+IV.
75 healthy subjects.

Primary Outcomes

Measure
decrease in peripheral systolic blood pressure at night
time frame: < 24 hours

Secondary Outcomes

Measure
decrease in central systolic blood pressure at night
time frame: < 24 hours
difference in peripheral and central systolic and diastolic blood pressure throughout the day, during the daytime and during nighttime
time frame: < 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.
time frame: < 24 hours
U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel)
time frame: 24 hours
PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin.
time frame: < 1 hour

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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 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 - Smoking - 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.

Additional Information

Official title Nocturnal Blood Pressure in Chronic Kidney Disease, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Regional Hospital Holstebro.