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

8 oktober 2014 uppdaterad 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.

Studieöversikt

Status

Okänd

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

150

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

55 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

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

Vad mäter studien?

Primära 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 peripheral 24-h BP between patients with hypertension 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 the central 24-h BP between patients with hypertension and healthy subjects.	< 24 hours
difference i blood pressure levels throughout the day Tidsram: < 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. Tidsram: < 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 Tidsram: 24 hours	In 24-h urine samples	24 hours
PRC, p-AngII, p-aldosterone, p-AVP, p-endothelin Tidsram: < 1 hour	blood samples	< 1 hour

Samarbetspartners och utredare

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

Sponsor

Erling Bjerregaard Pedersen

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 januari 2014

Primärt slutförande (Förväntat)

1 december 2015

Avslutad studie (Förväntat)

1 december 2017

Studieregistreringsdatum

Först inskickad

1 mars 2014

Först inskickad som uppfyllde QC-kriterierna