- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04023214
The Role of Endothelial Dysfunction in Adult Polycystic Kidney Disease
Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Following recruitment we will record the following baseline demographics; age, gender, smoking status, body mass index, medical history.
Participants will undergo a noninvasive vascular assessment, venepuncture and will provide a urine sample.This will be done during a single visit to the CRF.
Noninvasive vascular assessment will consist of:
Peripheral Arterial Tonometry This will be measured using the EndoPAT system (Itamar Medical)
Endothelial shear stress flow stimulus will be provided by inflation of a blood pressure cuff around the upper non-dominant arm to suprasystolic pressure (but <300mmHg) for 5 minutes. Following release of the cuff the resulting digital microcirculation vasodilatory response to ischaemic hyperaemia, quantified as the pulse wave amplitude, will be monitored over 5 minutes. The peak pulse wave amplitude measured at 90-150s post cuff deflation relative to baseline will be indexed to the changes in the opposite arm to give the reactive hyperaemia index. This measure of endothelial function constitutes the outcome measure.
- Blood Pressure Assessment Brachial artery blood pressure will be measured in the left arm in the supine position using an automated device (Dinamap) and in accordance with the clinical research facility SOP.
- Blood samples and urine samples
Samples for plasma will be centrifuged and stored at -80C. Biochemical analysis will be performed by the laboratory of the STH NHS Trust for standard tests and by validated assays for non-routine markers (as detailed below) in the Academic Nephrology Unit.
Participants will be asked to collect a 24h urine sample from the day before the study visit and to provide a spot urine sample on the day. This will be analysed at the laboratory of the STH NHS Trust.
Biochemical Analysis
Serum samples will be analyzed for Full blood count, Urea, Electrolytes, Glucose, Insulin, Lipid Profile, Homocysteine, (Hs) CRP and Creatinine Levels.
Serum and plasma will also be stored for future analysis of relevant biomarkers of endothelial function or nitric oxide metabolism as indicated by preliminary results.
Urine samples will be analysed initially for protein creatinine ratio (PCR). The rest will be frozen for future analysis of urinary biomarkers of endothelial function or nitric oxide metabolism.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Age >18yrs, <50yrs
- Able to understand spoken/written English sufficiently to give informed consent and to take part in clinical assessment
- Clinical diagnosis of ADPKD
- eGFR >60ml/min/1.73m2
Exclusion Criteria:
- No history of cardiovascular disease or hypertension
- Not diabetic
- Not smoking
- Not breastfeeding
- Not pregnant
- Not taking any regular medication (except oral contraceptives)
- No musculoskeletal conditions contraindicating inflation of a blood pressure cuff to suprasystolic pressures around the forearm (as part of EndoPAT measurements)
- Not morbidly obese: BMI<35 (May contribute to endothelial dysfunction)
- eGFR <60ml/min/1.73m2
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Kontroller
Friske frivillige
|
This will be measured using the EndoPAT system (Itamar Medical)
|
|
ADPKD
ADPKD patients
|
This will be measured using the EndoPAT system (Itamar Medical)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Reactive hyperemia index (RHI)
Tidsramme: Baseline
|
EndoPAT values (Endoscore)
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Systolic and diastolic Blood pressure
Tidsramme: Baseline
|
mm Hg
|
Baseline
|
|
Proteinuria
Tidsramme: Baseline
|
Protein creatinine ratio
|
Baseline
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Albert Ong, STH
- Studieleder: Timothy Chico, STH
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
Andre studie-ID-numre
- STH15983
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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