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

8. oktober 2014 oppdatert 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.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

225

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
decrease in peripheral systolic blood pressure at night Tidsramme: < 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
decrease in central systolic blood pressure at night Tidsramme: < 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 Tidsramme: < 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. Tidsramme: < 24 hours		< 24 hours
U-AQP2 (urine aquaporin 2) og u-ENaCɣ (urine epithelial sodium channel) Tidsramme: 24 hours	24 hour urine sample.	24 hours
PRC (plasma renin concentration), p-AngII (angiotensin II), p-Aldosterone. P-Avp (vasopressin), p-Endothelin. Tidsramme: < 1 hour		< 1 hour

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Erling Bjerregaard Pedersen

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2013

Primær fullføring (Forventet)

1. desember 2015

Studiet fullført (Forventet)

1. oktober 2017

Datoer for studieregistrering

Først innsendt

23. september 2013

Først innsendt som oppfylte QC-kriteriene