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

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ClinicalTrials.gov Identifier: NCT01951196
Recruitment Status : Unknown
Verified October 2014 by Erling Bjerregaard Pedersen, Regional Hospital Holstebro.
Recruitment status was:  Active, not recruiting
First Posted : September 26, 2013
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro

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.


Condition or disease
Chronic Kidney Disease Obstructive Sleep Apnea

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.

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Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Nocturnal Blood Pressure in Chronic Kidney Disease, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure.
Study Start Date : October 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. decrease in peripheral systolic blood pressure at night [ Time Frame: < 24 hours ]
    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.


Secondary Outcome Measures :
  1. decrease in central systolic blood pressure at night [ Time Frame: < 24 hours ]
    The difference in the decrease in systolic BP at night by central 24-h BP between patients with chronic kidney disease and healthy subjects.

  2. difference in peripheral and central systolic and diastolic blood pressure throughout the day, during the daytime and during nighttime [ Time Frame: < 24 hours ]
    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.

  3. 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. [ Time Frame: < 24 hours ]
  4. U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel) [ Time Frame: 24 hours ]
    24 hour urine sample.

  5. PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin. [ Time Frame: < 1 hour ]

Biospecimen Retention:   Samples Without DNA
Whole blood, serum, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951196


Locations
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Denmark
Department of Medical Research and Medicine, Holstebro Regional Hospital
Holstebro, Denmark, 7500
Sponsors and Collaborators
Erling Bjerregaard Pedersen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Erling Bjerregaard Pedersen, professor, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT01951196    
Other Study ID Numbers: BGH-1-2013
M-2013-224-13 ( Other Identifier: The Regional Committee of Health Research Ethics )
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: October 9, 2014
Last Verified: October 2014
Keywords provided by Erling Bjerregaard Pedersen, Regional Hospital Holstebro:
Chronic kidney disease
24 hour blood pressure
central blood pressure
peripheral blood pressure
obstructive sleep apnea
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Kidney Diseases
Renal Insufficiency, Chronic
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Urologic Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Renal Insufficiency