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Trial record 1 of 22 for:    Hypertension | Oxford, United Kingdom
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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
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Hypertension Diagnostic Test: Echocardiography scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


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
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.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Maryam Alsharqi +44(0)1865 572832 maryam.alsharqi@cardiov.ox.ac.uk

Locations
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United Kingdom
Cardiovascular Clinical Research Facility Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Maryam Alsharqi    +44(0)1865 572832    maryam.alsharqi@cardiov.ox.ac.uk   
Sponsors and Collaborators
University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03762499    
Other Study ID Numbers: 247606
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Young adults
Echocardiography
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases