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

8 oktober 2014 uppdaterad av: Erling Bjerregaard Pedersen

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.

Studieöversikt

Status

Okänd

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

225

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Danmark
- - Holstebro, Danmark, 7500
    - Department of Medical Research and Medicine, Holstebro Regional Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
decrease in peripheral systolic blood pressure at night Tidsram: < 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.	< 24 hours

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
decrease in central systolic blood pressure at night Tidsram: < 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.	< 24 hours
difference in peripheral and central systolic and diastolic blood pressure throughout the day, during the daytime and during nighttime Tidsram: < 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.	< 24 hours
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. Tidsram: < 24 hours		< 24 hours
U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel) Tidsram: 24 hours	24 hour urine sample.	24 hours
PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin. Tidsram: < 1 hour		< 1 hour

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Erling Bjerregaard Pedersen

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Hornstrup BG, Gjoerup PH, Wessels J, Lauridsen TG, Pedersen EB, Bech JN. Nocturnal blood pressure decrease in patients with chronic kidney disease and in healthy controls - significance of obstructive sleep apnea and renal function. Int J Nephrol Renovasc Dis. 2018 Nov 8;11:279-290. doi: 10.2147/IJNRD.S176606. eCollection 2018.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2013

Primärt slutförande (Förväntat)

1 december 2015

Avslutad studie (Förväntat)

1 oktober 2017

Studieregistreringsdatum

Först inskickad

23 september 2013

Först inskickad som uppfyllde QC-kriterierna