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

NCT ID: NCT01951196

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 225 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-10-31

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.

Conditions

Chronic Kidney Disease; Obstructive Sleep Apnea

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Chronic kidney disease, CKD III+IV

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

No interventions assigned to this group

Healthy subjects

75 healthy subjects.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• eGFR 15-59 mL/min/1.73 m2 (estimated GFR)
• 18-80 years
• males and females

• 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

• 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:

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erling Bjerregaard Pedersen

OTHER

Sponsor Role: lead

Responsible Party

Erling Bjerregaard Pedersen

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Medical Research and Medicine, Holstebro Regional Hospital

Holstebro, Holstebro, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 30510439 (View on PubMed)

Other Identifiers

M-2013-224-13

Identifier Type: OTHER

Identifier Source: secondary_id

BGH-1-2013

Identifier Type: -

Identifier Source: org_study_id