Hypertension Management in Young Adults Personalised by Echocardiography and Clinical Outcome.

Not Applicable

Recruiting

• Conditions: Hypertension
• Interventions: Diagnostic Test: Echocardiography scan

• Registration Number: NCT03762499
• Lead Sponsor: University of Oxford

Brief Summary

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 young adult patients aged between 18 to 40 years old and referred to the hypertension clinic to manage their blood pressure. 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).

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 Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-02
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-30
• Last Update Submitted: 2018-11-30
• Study First Posted: 2018-12-03
• Last Update Posted: 2018-12-03
• Primary Completion: 2021-09-01
• Study Completion: 2028-10-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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.

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Exclusion Criteria

• Unable or unwilling to give valid consent for participation in the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospective participants	Echocardiography scan	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

Primary Outcome Measures

Name	Time	Method
Identification of patient clusters based on echocardiographic and clinical findings	Obtained at the first clinical visit	Number of hypertension patient clusters based on echocardiographic and clinical findings

Trial Locations

Locations (1)

Cardiovascular Clinical Research Facility; 🇬🇧 Oxford, United Kingdom