Hypertension Management in Young Adults Personalised by Echocardiography and Clinical Outcome. (HyperEcho)
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Echocardiography scan
Sponsored by

About this trial
This is an interventional diagnostic trial for Hypertension focused on measuring Young adults, Echocardiography
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.
Sites / Locations
- Cardiovascular Clinical Research FacilityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Prospective participants
Retrospective participants
Arm Description
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
500 participants will be recruited retrospectively, and no additional echocardiography scan will be required for them.
Outcomes
Primary Outcome Measures
Identification of patient clusters based on echocardiographic and clinical findings
Number of hypertension patient clusters based on echocardiographic and clinical findings
Secondary Outcome Measures
Full Information
NCT ID
NCT03762499
First Posted
November 6, 2018
Last Updated
November 30, 2018
Sponsor
University of Oxford
1. Study Identification
Unique Protocol Identification Number
NCT03762499
Brief Title
Hypertension Management in Young Adults Personalised by Echocardiography and Clinical Outcome.
Acronym
HyperEcho
Official Title
Hypertension Management in Young Adults Personalised by Echocardiography and Clinical Outcome.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
October 2, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Young adults, Echocardiography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prospective participants
Arm Type
Active Comparator
Arm Description
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
Arm Title
Retrospective participants
Arm Type
No Intervention
Arm Description
500 participants will be recruited retrospectively, and no additional echocardiography scan will be required for them.
Intervention Type
Diagnostic Test
Intervention Name(s)
Echocardiography scan
Intervention Description
Non-invasive ultrasound imaging of the heart.
Primary Outcome Measure Information:
Title
Identification of patient clusters based on echocardiographic and clinical findings
Description
Number of hypertension patient clusters based on echocardiographic and clinical findings
Time Frame
Obtained at the first clinical visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryam Alsharqi
Phone
+44(0)1865 572832
Email
maryam.alsharqi@cardiov.ox.ac.uk
Facility Information:
Facility Name
Cardiovascular Clinical Research Facility
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryam Alsharqi
Phone
+44(0)1865 572832
Email
maryam.alsharqi@cardiov.ox.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Hypertension Management in Young Adults Personalised by Echocardiography and Clinical Outcome.
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