- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04522765
Daglige BP-mønstre hos de med økt risiko for CVD
Daglig blodtrykk og arteriell stivhet mønstre hos de med økt risiko for kardiovaskulær sykdom
In health, blood pressure (BP) falls at night by >10% compared with day-time values. This natural dipping pattern is important as without it there is an increased risk of cardiovascular disease (CVD). Recent evidence suggests that chronotherapy (taking anti-hypertensive medication at bedtime instead of in the morning) may enhance nocturnal BP dipping and reduce the risk of CVD events. There is therefore an urgent need to characterise diurnal BP patterns in patients who may be at risk of reduced nocturnal dipping in order to maximise protective therapy in all those who would benefit. Similarly, it has previously been demonstrated that increased arterial stiffness is associated with increased CVD risk, however little is known about whether loss of diurnal variations in arterial stiffness confer addition risk. Kidney disease is independently associated with increased CVD events, but the exact makeup of this risk is not clear. Within this heterogenous cohort several very distinct groups exist including those with acute kidney injury (AKI), chronic kidney disease (CKD), inflammatory conditions like small vessel vasculitis (SVV), and those who have either donated or received a kidney transplant. Diurnal BP and arterial stiffness patterns within these patient groups are not well characterised. The investigators will recruit patients at increased risk of CVD from the Royal Infirmary of Edinburgh Renal and Vasculitis Clinics. Participants will undergo 24-hour ambulatory BP and arterial stiffness measurement in conjunction with day- and night-time blood and urine sampling on two separate occasions. This study aims to characterise diurnal patterns of BP and arterial stiffness in patients at increased risk of CVD and compare findings with healthy controls. In doing so, the investigators aim to allow more targeted CVD risk reduction strategies and improve long-term patient outcomes.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Neeraj Dhaun, MBChB PhD
- Telefonnummer: 07968810899
- E-post: bean.dhaun@ed.ac.uk
Studiesteder
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-
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Edinburgh, Storbritannia, EH164SA
- Rekruttering
- Royal Infirmary of Edinburgh
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Ta kontakt med:
- Neeraj Dhaun, MBChB PhD
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
As above
Beskrivelse
Inclusion Criteria:
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Patients will be eligible to take part in the study if they attend NHS Lothian inpatient or outpatient services and can be classified as being at increased risk of CVD. This will include, but is not limited to, the following subgroups:
- CKD as defined by the Kidney Disease Outcome Quality Initiative (K/DOQI) classification
- AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) classification
- Small vessel vasculitis
- Kidney transplant recipient
- Kidney donor We will also recruit a healthy control group from the community.
Exclusion Criteria:
- Age <18 years and >90 years
- Lack of ability to provide informed consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Health
Healthy individuals with no known medical condition and taking no regular medication |
Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device |
|
Acute kidney injury
Individuals with acute kidney injury as defined by KDIGO criteria |
Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device |
|
Chronic kidney disease
Individuals with chronic kidney disease as defined by KDIGO criteria |
Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device |
|
Small vessel vasculitis
Individuals with active small vessel vasculitis an diagnosed by a specialist physician |
Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device |
|
Kidney transplant recipient
Individuals who have received a kidney transplant |
Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device |
|
Kidney donor
Individuals who have donated a kidney for transplantation |
Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Nocturnal BP dip
Tidsramme: 24 hours
|
Percentage change between mean day-time and mean night-time blood pressure |
24 hours
|
|
Nocturnal arterial stiffness dip
Tidsramme: 24 hours
|
Percentage change between mean day-time and mean night-time arterial stiffness |
24 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in urine ET-1 concentration when measured in the morning (06:00 - 12:00) and in the evening (18:00-00:00)
Tidsramme: Morning (06:00-12:00) and evening (18:00-00:00)
|
Measurement of urine ET-1 concentration in the morning (06:00 - 12:00) and in the evening (18:00-00:00) |
Morning (06:00-12:00) and evening (18:00-00:00)
|
|
Change in plasma ET-1 concentration when measured in the morning (06:00 - 12:00) and in the evening (18:00-00:00)
Tidsramme: Morning (06:00-12:00) and evening (18:00-00:00)
|
Measurement of plasma ET-1 concentration in the morning (06:00 - 12:00) and in the evening (18:00-00:00) |
Morning (06:00-12:00) and evening (18:00-00:00)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Neeraj Dhaun, MBChB PhD, University of Edinburgh
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kronisk sykdom
- Sykdomsattributter
- Nyreinsuffisiens
- Patologiske tilstander, tegn og symptomer
- Nyresvikt, kronisk
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Sirkulasjons- og luftveisfysiologiske fenomener
- Fysisk undersøkelse
- Vitale tegn
- Hemodynamikk
- Kardiovaskulære fysiologiske fenomener
- Blodtrykk
- Vaskulær stivhet
Andre studie-ID-numre
- AC19178
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
There is no plan to share IPD
Legemiddel- og utstyrsinformasjon, studiedokumenter
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