- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05334355
Impact of a Family History of Hypertension and Physical Activity on Left Ventricular Mass
February 20, 2025 updated by: Evan Matthews, Montclair State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
74
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 32 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Young healthy normotensive adults who are capable of self reporting family history of hypertension.
Description
Inclusion Criteria:
- Generally healthy
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Positive Family History of Hypertension
Young normotensive generally healthy adult with one or more biological parents with diagnosed hypertension.
|
Presence or absence of a family history of hypertension in a cross sectional study design.
|
|
Negative Family History of Hypertension
Young normotensive generally healthy adult with no biological parent with diagnosed hypertension.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Left Ventricular Mass
Time Frame: Day 2
|
Muscle mass in grams of the left ventricle of the heart as estimated by ultrasound.
|
Day 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Evan L Matthews, PhD, Montclair State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 19, 2016
Primary Completion (Actual)
February 27, 2020
Study Completion (Actual)
February 27, 2020
Study Registration Dates
First Submitted
April 1, 2022
First Submitted That Met QC Criteria
April 12, 2022
First Posted (Actual)
April 19, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 20, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-FY15-16-185 & 19-20-1602
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data is available on the Montclair State University Digital Commons website.
IPD Sharing Time Frame
The data is currently available with no expiration date.
IPD Sharing Access Criteria
Publicly available
Study Data/Documents
-
Individual Participant Data Set
Information comments: Complete individual participant data set is publicly available on the Montclair State University Digital Commons.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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