Genetic PredispositionNCT05334355
Impact of a Family History of Hypertension and Physical Activity on Left Ventricular Mass
An observational study of Genetic Predisposition and Genetic Hypertension, run by Montclair State University.
Trial summary
This is a retrospective analysis of data collected within two previous studies. The data has been combined and used to investigate the impact of having a family history of hypertension on left ventricular muscle mass with and without controlling for moderate and vigorous intensity physical activity frequency per week. Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Genetic Predisposition, Genetic Hypertension
- What is being tested?
- Family history of hypertension
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 19 Apr 2016to 27 Feb 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young healthy normotensive adults who are capable of self reporting family history of hypertension.
Who may be able to join
- Generally healthy
Who cannot join
- Known hypertension, cardiovascular disease, current pregnancy, current infectious disease, diabetes mellitus, kidney disease, a history of cancer, pulmonary disease, history of a stroke, obesity (for most people this means a body mass index greater than 30), or any life threatening chronic conditions
About this study
This is a retrospective analysis of data collected within two previous studies. The data has been combined and used to investigate the impact of having a family history of hypertension on left ventricular muscle mass with and without controlling for moderate and vigorous intensity physical activity frequency per week. The hypothesis was that in a sample of mostly active participants, no differences in left ventricular mass between family history of hypertension groups would be observed, but the positive family history of hypertension group would have elevated left ventricular mass compared to the negative family history of hypertension group following statistical control of activity frequency.
Read the detailed description
A positive family history of hypertension (FHH) (+FHH) is associated with elevated left ventricular mass (LVM). Regular physical activity (PA) may eliminate differences in LVM between +FHH and negative family history of hypertension (-FHH) adults. PURPOSE: To determine if a +FHH is associated with a greater LVM compared to a -FHH group within a sample of young, mostly active healthy adults with and without statistically controlling for PA. METHODS: Healthy young (18-32yrs) participants self-reported FHH status and habitual moderate and vigorous PA frequency. Participants then underwent an echocardiogram.
- Conditions
- Genetic Predisposition, Genetic Hypertension
- Being tested
- Family history of hypertension
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family history of hypertensionOther
Presence or absence of a family history of hypertension in a cross sectional study design.
| Study group | Role | What they receive |
|---|---|---|
| Positive Family History of Hypertension | Young normotensive generally healthy adult with one or more biological parents with diagnosed hypertension. Receives: Other: Family history of hypertension | |
| Negative Family History of Hypertension | Young normotensive generally healthy adult with no biological parent with diagnosed hypertension. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Mass
Muscle mass in grams of the left ventricle of the heart as estimated by ultrasound.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start19 Apr 2016
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genetic PredispositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montclair State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evan Matthews, Montclair State University
- Investigators
- Evan L Matthews, PhD, Principal investigator, Montclair State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334355
- Sponsor's protocol ID
- IRB-FY15-16-185 & 19-20-1602
- Status last verified
- Feb 2025
- First submitted
- 1 Apr 2022
- Last updated
- 24 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data is available on the Montclair State University Digital Commons website.
Publications
Callaghan KN, Hosick PA, Brian MS, Matthews EL. Impact of a family history of hypertension and physical activity on left ventricular mass. J Sports Med Phys Fitness. 2023 Aug;63(8):949-956. doi: 10.23736/S0022-4707.23.14877-8. Epub 2023 May 9.
PubMed 37158799
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Family History of Hypertension and Physical Activity on Left Ventricular Mass
- ClinicalTrials.gov ID
- NCT05334355
- Acronym / sponsor ID
- IRB-FY15-16-185 & 19-20-1602
- Conditions
- Genetic Predisposition, Genetic Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Montclair State UniversityUniversity, hospital or other
- Study start
- 19 Apr 2016 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Posted 24 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective analysis of data collected within two previous studies. The data has been combined and used to investigate the impact of having a family history of hypertension on left ventricular muscle mass with and without controlling for moderate and vigorous intensity physical activity frequency per week. The hypothesis was that in a sample of mostly active participants, no differences in left ventricular mass between family history of hypertension groups would be observed, but the positive family history of hypertension group would have elevated left ventricular mass compared to the negative family history of hypertension group following statistical control of activity frequency.
Detailed description
A positive family history of hypertension (FHH) (+FHH) is associated with elevated left ventricular mass (LVM). Regular physical activity (PA) may eliminate differences in LVM between +FHH and negative family history of hypertension (-FHH) adults. PURPOSE: To determine if a +FHH is associated with a greater LVM compared to a -FHH group within a sample of young, mostly active healthy adults with and without statistically controlling for PA. METHODS: Healthy young (18-32yrs) participants self-reported FHH status and habitual moderate and vigorous PA frequency. Participants then underwent an echocardiogram.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Family History of Hypertension | – | Other: Family history of hypertensionYoung normotensive generally healthy adult with one or more biological parents with diagnosed hypertension. |
| Negative Family History of Hypertension | – | –Young normotensive generally healthy adult with no biological parent with diagnosed hypertension. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young healthy normotensive adults who are capable of self reporting family history of hypertension.
Key inclusion criteria (1 listed)
- Generally healthy
Key exclusion criteria (1 listed)
- Known hypertension, cardiovascular disease, current pregnancy, current infectious disease, diabetes mellitus, kidney disease, a history of cancer, pulmonary disease, history of a stroke, obesity (for most people this means a body mass index greater than 30), or any life threatening chronic conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family history of hypertensionPresence or absence of a family history of hypertension in a cross sectional study design. | Other | Positive Family History of Hypertension |
Primary outcome
Left Ventricular Mass
Time frame: Day 2
Muscle mass in grams of the left ventricle of the heart as estimated by ultrasound.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37158799Callaghan KN, Hosick PA, Brian MS, Matthews EL. Impact of a family history of hypertension and physical activity on left ventricular mass. J Sports Med Phys Fitness. 2023 Aug;63(8):949-956. doi: 10.23736/S0022-4707.23.14877-8. Epub 2023 May 9.
- Individual participant dataSharing planned: Yes. Individual participant data is available on the Montclair State University Digital Commons website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan L Matthews, PhD principal investigator
Montclair State University
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Predisposition and Genetic Hypertension, run by Montclair State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Mass (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05334355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.