- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03762499
Hypertension Management in Young Adults Personalised by Echocardiography and Clinical Outcome. (HyperEcho)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
HyperEcho is a multi-centre longitudinal observational study, to investigate whether baseline transthoracic echocardiography along with routine data collected in the hypertension clinic can guide clinicians to better manage, and improve risk stratification for cardiovascular disease in young adults with hypertension. Participants are characterised as hypertensive patients aged between 18 to 40 years old and referred to the hypertension clinic to manage their blood pressure. A patient and public involvement exercise has been performed to ensure this study design would appeal to patients attending the hypertension clinic, and to investigate the preferred method of contact.
The study visit will be carried out during the planned routine visit of the participants to the hypertension clinics of NHS trusts within England. Routine data will be collected by the assigned nurse for the hypertension clinic as part of the clinical service, and research participation will not affect the clinical progress of the participant. The additional research component to the clinic will be asking the participants for their consent to undergo a research echocardiography scan if it has not been a part of their clinical assessment. Participants will also be asked to consent to the use of their data that has been collected in the hypertension clinic, such as; referral letters, medical history, 24-hour blood pressure monitoring report, ECG, blood samples, body fat composition, and dietary questionnaire. In addition to this, participants will be asked to consent to further review of their data and medical notes during their follow up visits (up to 10 years).
Previous young adult patients who visited the Hypertension clinics in the last 10 years will be also recruited. This cohort will be asked to consent to allow the research team to collect and use their clinical data as well as follow up their medical notes. They will not actively participate in the study as they will not require visiting the hypertension clinic or undergoing an echocardiography scan.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Maryam Alsharqi
- Telefonnummer: +44(0)1865 572832
- E-post: maryam.alsharqi@cardiov.ox.ac.uk
Studieorter
-
-
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Oxford, Storbritannien, OX3 9DU
- Rekrytering
- Cardiovascular Clinical Research Facility
-
Kontakt:
- Maryam Alsharqi
- Telefonnummer: +44(0)1865 572832
- E-post: maryam.alsharqi@cardiov.ox.ac.uk
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 - 40 years (at the time of their appointment at the hypertension clinic).
- Referred for a Hypertension Clinic in England.
Exclusion Criteria:
- Unable or unwilling to give valid consent for participation in the study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Prospective participants
250 participants will be recruited prospectively during the hypertension clinic, where a full set of data will be collected from each participant as part of their standard hypertension clinical service.
An additional echocardiography scan will be performed for this cohort by the study team, if the scan has not been performed as a part of the clinical care service
|
Non-invasive ultrasound imaging of the heart.
|
Inget ingripande: Retrospective participants
500 participants will be recruited retrospectively, and no additional echocardiography scan will be required for them.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Identification of patient clusters based on echocardiographic and clinical findings
Tidsram: Obtained at the first clinical visit
|
Number of hypertension patient clusters based on echocardiographic and clinical findings
|
Obtained at the first clinical visit
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 247606
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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