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.
Přehled studie
Postavení
Detailní popis
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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Holstebro, Dánsko, 7500
- Department of Medical Research and Medicine, Holstebro Regional Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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decrease in peripheral systolic blood pressure at night
Časové okno: < 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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decrease in central systolic blood pressure at night
Časové okno: < 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
Časové okno: < 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.
Časové okno: < 24 hours
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< 24 hours
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U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel)
Časové okno: 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.
Časové okno: < 1 hour
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< 1 hour
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci nervového systému
- Nemoci dýchacích cest
- Poruchy dýchání
- Poruchy spánku, vnitřní
- Dysomnie
- Poruchy spánku a bdění
- Urologická onemocnění
- Renální insuficience
- Příznaky a symptomy, Respirační
- Syndromy spánkové apnoe
- Spánková apnoe, obstrukční
- Onemocnění ledvin
- Renální insuficience, chronická
- Apnoe
Další identifikační čísla studie
- BGH-1-2013
- M-2013-224-13 (Jiný identifikátor: The Regional Committee of Health Research Ethics)
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