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

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

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea; Chronic Kidney Disease

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.

• Study Type: Observational
• Enrollment (Anticipated): 225

Contacts and Locations

Study Locations

• Denmark
  • Holstebro, Denmark, 7500
    • Department of Medical Research and Medicine, Holstebro Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Chronic kidney disease, CKD III+IV; 150 patients with Chronic kidney disease, CKD stage III+IV.
Healthy subjects; 75 healthy subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decrease in peripheral systolic blood pressure at night	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.	< 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decrease in central systolic blood pressure at night	The difference in the decrease in systolic BP at night by central 24-h BP between patients with chronic kidney disease and healthy subjects.	< 24 hours
difference in peripheral and central systolic and diastolic blood pressure throughout the day, during the daytime and during nighttime	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.	< 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.		< 24 hours
U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel)	24 hour urine sample.	24 hours
PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin.		< 1 hour

Collaborators and Investigators

• Sponsor: Erling Bjerregaard Pedersen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: September 23, 2013
• First Submitted That Met QC Criteria: September 23, 2013
• First Posted (Estimate): September 26, 2013

Study Record Updates

• Last Update Posted (Estimate): October 9, 2014
• Last Update Submitted That Met QC Criteria: October 8, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; Chronic kidney disease; central blood pressure; 24 hour blood pressure; peripheral blood pressure
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Urologic Diseases; Renal Insufficiency; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Kidney Diseases; Renal Insufficiency, Chronic; Apnea
• Other Study ID Numbers: BGH-1-2013; M-2013-224-13 (Other Identifier: The Regional Committee of Health Research Ethics)