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

8. oktober 2014 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Erling Bjerregaard Pedersen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2014

Primær færdiggørelse (Forventet)

1. december 2015

Studieafslutning (Forventet)

1. december 2017

Datoer for studieregistrering

Først indsendt

1. marts 2014

Først indsendt, der opfyldte QC-kriterier

1. marts 2014

Først opslået (Skøn)

5. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. oktober 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. oktober 2014

Sidst verificeret

1. oktober 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BGH-2-2013
  • M-2013-303-13 (Anden identifikator: The Regional Committee of health Reseach Ethics)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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