- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03762499
Hypertension Management in Young Adults Personalised by Echocardiography and Clinical Outcome. (HyperEcho)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maryam Alsharqi
- Phone Number: +44(0)1865 572832
- Email: maryam.alsharqi@cardiov.ox.ac.uk
Study Locations
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Oxford, United Kingdom, OX3 9DU
- Recruiting
- Cardiovascular Clinical Research Facility
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Contact:
- Maryam Alsharqi
- Phone Number: +44(0)1865 572832
- Email: maryam.alsharqi@cardiov.ox.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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No Intervention: Retrospective participants
500 participants will be recruited retrospectively, and no additional echocardiography scan will be required for them.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of patient clusters based on echocardiographic and clinical findings
Time Frame: Obtained at the first clinical visit
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Number of hypertension patient clusters based on echocardiographic and clinical findings
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Obtained at the first clinical visit
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 247606
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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