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Nocturnal Blood Pressure and Hypertension - Central and Peripheral 24-h Blood Pressure. (HOSA)

8. oktober 2014 oppdatert av: Erling Bjerregaard Pedersen

Nocturnal Blood Pressure in Hypertension, Obstructive Sleep Apnea and Healthy Subjects - Central and Peripheral 24-h Blood Pressure

A new study have shown that high night time blood pressure (BP) and/or non-dipping (lack of fall in BP during night time) is a strong predictor for the risk of cardiovascular disease and mortality in patients with hypertension. Three factors seem to affect the night time BP: chronic kidney disease, obstructive sleep apnea (OSA) and the way ambulatory blood pressure is monitored.

Hypothesis:

Central 24-h blood pressure monitoring is a better way of monitoring blood pressure than conventional peripheral monitoring.

In hypertension, chronic kidney disease and obstructive sleep apnea (OSA) the night time blood pressure is elevated, and is OSA the elevation is correlated to the severity of OSA.

In OSA the kidneys handling of salt and water is disturbed. In OSA there is disturbances in hormonal balance.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

75 patients with hypertension and chronic kidney disease (CKD I-II) and 75 healthy subjects 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 (OSA), and if so the degree (apnea hypopnea index, AHI), blood and urine samples to determine levels of urine aquaporine2 (u-AQP2), urine endothelial sodium channel (u-EnaC), plasma renin concentration (PRC), plasma angiotensin II (p-AngII), plasma aldosterone (p-aldosterone), plasma vasopressin (p-AVP) and plasma endothelin (p-endothelin).

Hypothesis:

Central 24-h BP monitoring provides another measure of daily fluctuations in blood pressure than peripheral 24-h BP monitoring, because this measurement is painless and does not interfere with activities in the daytime or night-time sleep.

In hypertension, chronic kidney disease and OSA the decease in nocturnal BP is lower than i healthy subjects.

In OSA the decrease in the nocturnal BP is inversely correlated with the severity of OSA.

In OSA is the renal tubular absorption of water and sodium abnormal with increased tubular absorption of water with AQP2 and of sodium by ENAC.

In OSA, there is increased activity of the renin-angiotensin-aldosterone system, increased endothelin in plasma and increased vasopressin in plasma.

Studietype

Observasjonsmessig

Registrering (Forventet)

150

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

55 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Group 1: 75 patients with hypertension, recruited from another study in the Holstebro Area, contacted by letter.

Group 2: healthy subjects are recruited though posters in public and private companies as well as advertising in local media.

Beskrivelse

Group 1:

Inclusion Criteria:

Chronic kidney disease (CKD stage I and II), estimated glomerule filtration rate (eGFR) 60-90 ml/min/1.73 m2 or eGFR> 90 ml/min/1.73 m2 and proteinuria or other signs of kidney damage.
Hypertension (BP by ambulatory or home blood pressure> 135/85 mmHg, or consultation blood pressure> 140/90 mmHg).
Both men and women
55-70 years
A completed consent form

Exclusion Criteria:

Lack of desire to participate
In the treatment of OSA
Malignant disease
Abuse of drugs or alcohol
Pregnant and breastfeeding
Incompensated heart failure
Atrial fibrillation
Liver disease (Alanine aminotransferase (ALT)> 200)
Severe chronic obstructive pulmonary disease (COPD) (Forced expiratory volume in 1 second <50% predicted)
eGFR <60 ml/min/1.73 m2
Blood pressure difference between the right and left arm> 10/10 mmHg

Group 2 - Healthy subjects

Inclusion Criteria:

Healthy subjects men and women
age 55 - 70 years
Body mass index within the normal range, between 18.5 to 25.0 kg/m2

Exclusion Criteria:

Arterial hypertension, 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
- Medical 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 (B-hemoglobin and B-White blood cell count, p-sodium, p-potassium, p-creatinine, p-ALT, p-bilirubin , p-Alkaline phosphatase, p-cholesterol, p-albumin or b-glucose and urine for hematuria, albuminuria or glucosuria)
- Clinically significant variations in the electrocardiogram
- Blood Donation for the past month preceding the day on the first attempt sequence
- Blood pressure difference between the right and left arm> 10/10 mmHg.

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
hypertension 75 patients with hypertension and chronic kidney disease (CKD stage I-II)
healthy subjects 75 healthy subjects

Hva måler studien?

Primære 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 peripheral 24-h BP between patients with hypertension 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 the central 24-h BP between patients with hypertension and healthy subjects.	< 24 hours
difference i blood pressure levels throughout the day Tidsramme: < 24 hours	The difference in systolic blood pressure and diastolic blood pressure throughout the day, in the daytime and in nighttime between peripheral 24-h and central 24-h monitoring in both patients and healthy.	< 24 hours
The correlation between the decrease in nighttime BP on one side and severity of OSA and BP in the daytime on the other. Tidsramme: < 24 hours	The correlation between the decrease in nighttime BP on one side and severity of OSA and BP in the daytime on the other.	< 24 hours
u-AQP2 and u-ENac Tidsramme: 24 hours	In 24-h urine samples	24 hours
PRC, p-AngII, p-aldosterone, p-AVP, p-endothelin Tidsramme: < 1 hour	blood samples	< 1 hour

Samarbeidspartnere og etterforskere

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

Sponsor

Erling Bjerregaard Pedersen

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. januar 2014

Primær fullføring (Forventet)

1. desember 2015

Studiet fullført (Forventet)

1. desember 2017

Datoer for studieregistrering

Først innsendt

1. mars 2014

Først innsendt som oppfylte QC-kriteriene