Hypertension Management in Young Adults Personalised by Echocardiography and Clinical Outcome. (HyperEcho)
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|ClinicalTrials.gov Identifier: NCT03762499|
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Diagnostic Test: Echocardiography scan||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Hypertension Management in Young Adults Personalised by Echocardiography and Clinical Outcome.|
|Actual Study Start Date :||October 2, 2018|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||October 2, 2028|
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
Diagnostic Test: Echocardiography scan
Non-invasive ultrasound imaging of the heart.
No Intervention: Retrospective participants
500 participants will be recruited retrospectively, and no additional echocardiography scan will be required for them.
- Identification of patient clusters based on echocardiographic and clinical findings [ Time Frame: Obtained at the first clinical visit ]Number of hypertension patient clusters based on echocardiographic and clinical findings
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762499
|Contact: Maryam Alsharqi||+44(0)1865 email@example.com|
|Cardiovascular Clinical Research Facility||Recruiting|
|Oxford, United Kingdom, OX3 9DU|
|Contact: Maryam Alsharqi +44(0)1865 572832 firstname.lastname@example.org|