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

NCT01951196 | Unknown

• 2 other identifiers: BGH-1-2013M-2013-224-13
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Obstructive Sleep Apnea

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• decrease in central systolic blood pressure at night

  < 24 hours

• difference in peripheral and central systolic and diastolic blood pressure throughout the day, during the daytime and during nighttime

  < 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 hours

• PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin.

  < 1 hour

Study Arms (2)

Chronic kidney disease, CKD III+IV

150 patients with Chronic kidney disease, CKD stage III+IV.

Healthy subjects

75 healthy subjects.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• eGFR 15-59 mL/min/1.73 m2 (estimated GFR)
• years
• males and females

You may not qualify if:

• 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:
• Healthy volunteers men and women
• age 40 - 80 years
• BMI within the normal range, ie. between 18.5 to 25.0 kg/m2
• 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

Sponsors & Collaborators

• Erling Bjerregaard Pedersen: lead

Study Sites (1)

Department of Medical Research and Medicine, Holstebro Regional Hospital

Holstebro, Holstebro, 7500, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30510439 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum, urine

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: September 26, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: October 1, 2017
• Last Updated: October 9, 2014

Record last verified: 2014-10

Locations

DK (1)