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

8 octobre 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

225

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
decrease in peripheral systolic blood pressure at night Délai: < 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

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Erling Bjerregaard Pedersen

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2013

Achèvement primaire (Anticipé)

1 décembre 2015

Achèvement de l'étude (Anticipé)

1 octobre 2017

Dates d'inscription aux études

Première soumission

23 septembre 2013

Première soumission répondant aux critères de contrôle qualité