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

Obstructive Sleep Apnea Clinical Trial

— NOSA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01951196
• Other study ID #: BGH-1-2013
• Secondary ID: M-2013-224-13
• Status: Active, not recruiting
• Phase: N/A
• First received: September 23, 2013
• Last updated: October 8, 2014
• Start date: October 2013
• Est. completion date: October 2017

Study information

• Verified date: October 2014
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: October 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Obstructive Sleep Apnea
• Renal Insufficiency, Chronic
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Denmark	Department of Medical Research and Medicine, Holstebro Regional Hospital	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Erling Bjerregaard Pedersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	U-AQP2 (urine aquaporin 2) og u-ENaC? (urine epithelial sodium channel)	24 hour urine sample.	24 hours	No
Secondary	PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin.		< 1 hour	No