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Recruiting NCT03762499

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

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Echocardiography scan.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test Echocardiography scan
    Non-invasive ultrasound imaging of the heart.

Primary outcome measures

  • Identification of patient clusters based on echocardiographic and clinical findings [Time frame: Obtained at the first clinical visit]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Diagnostic

Study locations

United Kingdom · 1 center
  • Cardiovascular Clinical Research Facility — Oxford

Identifiers

NCT: NCT03762499 · 247606

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗