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Clinical Trials/NCT02078765
NCT02078765
Unknown
Not Applicable

Nocturnal Blood Pressure in Hypertension, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure

Erling Bjerregaard Pedersen1 site in 1 country150 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Erling Bjerregaard Pedersen
Enrollment
150
Locations
1
Primary Endpoint
decrease in central systolic blood pressure at night
Last Updated
11 years ago

Overview

Brief Summary

A new study have shown that high night time blood pressure (BP) and/or non-dipping (lack of fall in BP during night time) is a strong predictor for the risk of cardiovascular disease and mortality in patients with hypertension. Three factors seem to affect the night time BP: chronic kidney disease, obstructive sleep apnea (OSA) and the way ambulatory blood pressure is monitored.

Hypothesis:

Central 24-h blood pressure monitoring is a better way of monitoring blood pressure than conventional peripheral monitoring.

In hypertension, chronic kidney disease and obstructive sleep apnea (OSA) the night time blood pressure is elevated, and is OSA the elevation is correlated to the severity of OSA.

In OSA the kidneys handling of salt and water is disturbed. In OSA there is disturbances in hormonal balance.

Detailed Description

75 patients with hypertension and chronic kidney disease (CKD I-II) and 75 healthy subjects 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 (OSA), and if so the degree (apnea hypopnea index, AHI), blood and urine samples to determine levels of urine aquaporine2 (u-AQP2), urine endothelial sodium channel (u-EnaC), plasma renin concentration (PRC), plasma angiotensin II (p-AngII), plasma aldosterone (p-aldosterone), plasma vasopressin (p-AVP) and plasma endothelin (p-endothelin). Hypothesis: Central 24-h BP monitoring provides another measure of daily fluctuations in blood pressure than peripheral 24-h BP monitoring, because this measurement is painless and does not interfere with activities in the daytime or night-time sleep. In hypertension, chronic kidney disease and OSA the decease in nocturnal BP is lower than i healthy subjects. In OSA the decrease in the nocturnal BP is inversely correlated with the severity of OSA. In OSA is the renal tubular absorption of water and sodium abnormal with increased tubular absorption of water with AQP2 and of sodium by ENAC. In OSA, there is increased activity of the renin-angiotensin-aldosterone system, increased endothelin in plasma and increased vasopressin in plasma.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
December 2017
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Erling Bjerregaard Pedersen
Responsible Party
Sponsor Investigator
Principal Investigator

Erling Bjerregaard Pedersen

professor

Regional Hospital Holstebro

Eligibility Criteria

Inclusion Criteria

  • Chronic kidney disease (CKD stage I and II), estimated glomerule filtration rate (eGFR) 60-90 ml/min/1.73 m2 or eGFR\> 90 ml/min/1.73 m2 and proteinuria or other signs of kidney damage.
  • Hypertension (BP by ambulatory or home blood pressure\> 135/85 mmHg, or consultation blood pressure\> 140/90 mmHg).
  • Both men and women
  • 55-70 years
  • A completed consent form

Exclusion Criteria

  • Lack of desire to participate
  • In the treatment of OSA
  • Malignant disease
  • Abuse of drugs or alcohol
  • Pregnant and breastfeeding
  • Incompensated heart failure
  • Atrial fibrillation
  • Liver disease (Alanine aminotransferase (ALT)\> 200)
  • Severe chronic obstructive pulmonary disease (COPD) (Forced expiratory volume in 1 second \<50% predicted)
  • eGFR \<60 ml/min/1.73 m2

Outcomes

Primary Outcomes

decrease in central systolic blood pressure at night

Time Frame: < 24 hours

The difference in the decrease in systolic BP at night by peripheral 24-h BP between patients with hypertension and healthy subjects.

Secondary Outcomes

  • decrease in central systolic blood pressure at night(< 24 hours)
  • The correlation between the decrease in nighttime BP on one side and severity of OSA and BP in the daytime on the other.(< 24 hours)
  • difference i blood pressure levels throughout the day(< 24 hours)
  • u-AQP2 and u-ENac(24 hours)
  • PRC, p-AngII, p-aldosterone, p-AVP, p-endothelin(< 1 hour)

Study Sites (1)

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