Clinical trial NCT01951196: Nocturnal Blood Pressure - Central and Peripheral 24-h Blood Pressure in Chronic Kidney Disease.
Official title: Nocturnal Blood Pressure in Chronic Kidney Disease, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Obstructive Sleep Apnea
Keywords: Chronic kidney disease
24 hour blood pressure
central blood pressure
peripheral blood pressure
obstructive sleep apnea
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2013-09-26
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1: Patients with chronic kidney disease, CKD stage III-IV. The patients is followed for their kidney disease at Holstebro Regional Hospital, Denmark, Medical clinic, and the are chosen to participate in the study because of this relation.

Group 2: Healthy subjects. They arerecruited through postings on public and private companies as well as advertising in local medier.

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.

Eligibility 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

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.

Primary outcomes:
measure: decrease in peripheral systolic blood pressure at night
timeFrame: < 24 hours
Secondary outcomes:
measure: decrease in central systolic blood pressure at night
timeFrame: < 24 hours
measure: difference in peripheral and central systolic and diastolic blood pressure throughout the day, during the daytime and during nighttime
timeFrame: < 24 hours
measure: 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.
timeFrame: < 24 hours
measure: U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel)
timeFrame: 24 hours
measure: PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin.
timeFrame: < 1 hour
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medical Research and Medicine, Holstebro Regional Hospital
Study officials:
References:
citation: Hornstrup BG, Gjoerup PH, Wessels J, Lauridsen TG, Pedersen EB, Bech JN. Nocturnal blood pressure decrease in patients with chronic kidney disease and in healthy controls - significance of obstructive sleep apnea and renal function. Int J Nephrol Renovasc Dis. 2018 Nov 8;11:279-290. doi: 10.2147/IJNRD.S176606. eCollection 2018.