- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04522765
Modelli di PA diurni in quelli a rischio aumentato di CVD
Modelli di pressione sanguigna diurna e rigidità arteriosa in soggetti ad aumentato rischio di malattie cardiovascolari
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Neeraj Dhaun, MBChB PhD
- Numero di telefono: 07968810899
- Email: bean.dhaun@ed.ac.uk
Luoghi di studio
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Edinburgh, Regno Unito, EH164SA
- Reclutamento
- Royal Infirmary of Edinburgh
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Contatto:
- Neeraj Dhaun, MBChB PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
As above
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Nocturnal BP dip
Lasso di tempo: 24 hours
|
Percentage change between mean day-time and mean night-time blood pressure |
24 hours
|
|
Nocturnal arterial stiffness dip
Lasso di tempo: 24 hours
|
Percentage change between mean day-time and mean night-time arterial stiffness |
24 hours
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in urine ET-1 concentration when measured in the morning (06:00 - 12:00) and in the evening (18:00-00:00)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Neeraj Dhaun, MBChB PhD, University of Edinburgh
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Processi patologici
- Malattie urogenitali maschili
- Malattie renali
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattia cronica
- Attributi della malattia
- Insufficienza renale
- Condizioni patologiche, segni e sintomi
- Insufficienza renale cronica
- Tecniche e procedure diagnostiche
- Diagnosi
- Fenomeni fisiologici circolatori e respiratori
- Esame fisico
- Segni vitali
- Emodinamica
- Fenomeni fisiologici cardiovascolari
- Pressione sanguigna
- Rigidità vascolare
Altri numeri di identificazione dello studio
- AC19178
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
There is no plan to share IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .