Nocturnal Blood Pressure - Central and Peripheral 24-h Blood Pressure in Chronic Kidney Disease. (NOSA)
Nocturnal Blood Pressure in Chronic Kidney Disease, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure.
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Holstebro, Dänemark, 7500
- Department of Medical Research and Medicine, Holstebro Regional Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Chronic kidney disease, CKD III+IV
150 patients with Chronic kidney disease, CKD stage III+IV.
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Healthy subjects
75 healthy subjects.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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decrease in peripheral systolic blood pressure at night
Zeitfenster: < 24 hours
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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.
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< 24 hours
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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decrease in central systolic blood pressure at night
Zeitfenster: < 24 hours
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The difference in the decrease in systolic BP at night by central 24-h BP between patients with chronic kidney disease and healthy subjects.
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< 24 hours
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difference in peripheral and central systolic and diastolic blood pressure throughout the day, during the daytime and during nighttime
Zeitfenster: < 24 hours
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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.
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< 24 hours
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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.
Zeitfenster: < 24 hours
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< 24 hours
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U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel)
Zeitfenster: 24 hours
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24 hour urine sample.
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24 hours
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PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin.
Zeitfenster: < 1 hour
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< 1 hour
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Nervensystems
- Erkrankungen der Atemwege
- Atemstörungen
- Schlafstörungen, intrinsisch
- Dyssomnien
- Schlaf-Wach-Störungen
- Urologische Erkrankungen
- Niereninsuffizienz
- Anzeichen und Symptome, Atmung
- Schlafapnoe-Syndrome
- Schlafapnoe, obstruktiv
- Nierenerkrankungen
- Niereninsuffizienz, chronisch
- Apnoe
Andere Studien-ID-Nummern
- BGH-1-2013
- M-2013-224-13 (Andere Kennung: The Regional Committee of Health Research Ethics)
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