Healthy Active FemalesNCT07861893
CArdiovascular Phenotyping in Recreationally Active Saudi Women
An observational study of Healthy Active Females and Healthy Adult Female Participants, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
As Saudi Arabia undergoes a transformative shift in public health through Saudi Vision 2030, targeting an increase in weekly sports participation to 40%, the cardiovascular health of women engaging in regular physical activity has emerged as a critical and research priority. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Healthy Active Females, Healthy Adult Female Participants
- How many people
- 240 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2026to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Adult
Study population: This study will aim to recruit recreationally active Saudi women aged 18-45 years. Recreationally active is defined as self-reported engagement in regular structured exercise or physical activity ≥3 hours/week for ≥6 consecutive months. Exercise or physical activity modalities may include aerobic training (e.g. running, cycling, swimming, and group fitness classes), resistance training, or mixed training.
Who may be able to join
- Saudi female nationals or long-term residents (≥5 years)
- Age 18-45 years
- Able to provide written informed consent and willing to undergo all study procedures
- Recruited from the university community and/or participating female-only fitness centers
- Self-reported regular structured exercise or physical activity of ≥3 hours/week for ≥6 consecutive months (recreationally active)
Who cannot join
- Vulnerable adult unable to provide informed consent
- Known severe or terminal illness or comorbidities preventing participation
- Known cardiovascular disease (coronary artery disease, heart failure, congenital heart disease, cardiomyopathy, valvular disease, arrhythmia)
- Current pregnancy
- Uncontrolled hypertension ≥ 200/110 mmHg, per AHA guidelines
- Poor echocardiographic window precluding adequate image acquisition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: CArdiovascular Phenotyping in Recreationally Active Saudi Women: A Cross-Sectional Study Using Al-Assisted POint-of-Care UltraSound (CAPRAS-POCUS Study)
As Saudi Arabia undergoes a transformative shift in public health through Saudi Vision 2030, targeting an increase in weekly sports participation to 40%, the cardiovascular health of women engaging in regular physical activity has emerged as a critical and research priority. Despite the rapid expansion of female-only gyms and competitive sports, there remains a profound lack of regional, sex-specific echocardiographic normative data and subclinical screening evidence for the Saudi female population.
This study is a prospective, observational cross-sectional, community screening study using handheld Point-of-Care Ultrasound (POCUS) to characterize physiological cardiac remodeling in recreationally active Saudi women and identify subclinical structural heart disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Mass Index (LVMi)
LV mass in active Saudi women, calculated by the Devereux formula from 2D parasternal long-axis measurements using AI-assisted handheld POCUS, indexed to body surface area and reported in g/m².
Measured: Baseline
Left Ventricular End-Diastolic Diameter (LVEDDi)
LV end-diastolic diameter in active Saudi women, measured in the parasternal long-axis view using AI-assisted handheld POCUS, reported in mm.
Measured: Baseline
Left Ventricular End-Systolic Diameter (LVESD)
LV end-systolic diameter in active Saudi women, measured in the parasternal long-axis view using AI-assisted handheld POCUS and reported in mm.
Measured: Baseline
Interventricular Septal Thickness at End-Diastole (IVSd)
Interventricular septal thickness at end-diastole in active Saudi women, measured in the parasternal long-axis view using AI-assisted handheld POCUS and reported in mm.
Measured: Baseline
Left Ventricular Posterior Wall Thickness at End-Diastole (LVPWd)
LV posterior wall thickness at end-diastole in active Saudi women, measured in the parasternal long-axis view using AI-assisted handheld POCUS and reported in mm.
Measured: Baseline
Mitral Inflow E/A Ratio
Ratio of early (E) to late (A) diastolic mitral inflow velocities in active Saudi women, measured by pulsed-wave Doppler in the apical 4-chamber view using AI-assisted handheld POCUS and reported as a unitless ratio.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Active FemalesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamia Khaled Al Saikhan, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861893
- Sponsor's protocol ID
- IRB-2026-03-0641
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CArdiovascular Phenotyping in Recreationally Active Saudi Women: A Cross-Sectional Study Using Al-Assisted POint-of-Care UltraSound (CAPRAS-POCUS Study)
- ClinicalTrials.gov ID
- NCT07861893
- Acronym / sponsor ID
- IRB-2026-03-0641
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As Saudi Arabia undergoes a transformative shift in public health through Saudi Vision 2030, targeting an increase in weekly sports participation to 40%, the cardiovascular health of women engaging in regular physical activity has emerged as a critical and research priority. Despite the rapid expansion of female-only gyms and competitive sports, there remains a profound lack of regional, sex-specific echocardiographic normative data and subclinical screening evidence for the Saudi female population.
This study is a prospective, observational cross-sectional, community screening study using handheld Point-of-Care Ultrasound (POCUS) to characterize physiological cardiac remodeling in recreationally active Saudi women and identify subclinical structural heart disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- This study will aim to recruit recreationally active Saudi women aged 18-45 years. Recreationally active is defined as self-reported engagement in regular structured exercise or physical activity ≥3 hours/week for ≥6 consecutive months. Exercise or physical activity modalities may include aerobic training (e.g. running, cycling, swimming, and group fitness classes), resistance training, or mixed training.
Key inclusion criteria (5 listed)
- Saudi female nationals or long-term residents (≥5 years)
- Age 18-45 years
- Able to provide written informed consent and willing to undergo all study procedures
- Recruited from the university community and/or participating female-only fitness centers
- Self-reported regular structured exercise or physical activity of ≥3 hours/week for ≥6 consecutive months (recreationally active)
Key exclusion criteria (6 listed)
- Vulnerable adult unable to provide informed consent
- Known severe or terminal illness or comorbidities preventing participation
- Known cardiovascular disease (coronary artery disease, heart failure, congenital heart disease, cardiomyopathy, valvular disease, arrhythmia)
- Current pregnancy
- Uncontrolled hypertension ≥ 200/110 mmHg, per AHA guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Left Ventricular Mass Index (LVMi)
Time frame: Baseline
LV mass in active Saudi women, calculated by the Devereux formula from 2D parasternal long-axis measurements using AI-assisted handheld POCUS, indexed to body surface area and reported in g/m².
Left Ventricular End-Diastolic Diameter (LVEDDi)
Time frame: Baseline
LV end-diastolic diameter in active Saudi women, measured in the parasternal long-axis view using AI-assisted handheld POCUS, reported in mm.
Left Ventricular End-Systolic Diameter (LVESD)
Time frame: Baseline
LV end-systolic diameter in active Saudi women, measured in the parasternal long-axis view using AI-assisted handheld POCUS and reported in mm.
Interventricular Septal Thickness at End-Diastole (IVSd)
Time frame: Baseline
Interventricular septal thickness at end-diastole in active Saudi women, measured in the parasternal long-axis view using AI-assisted handheld POCUS and reported in mm.
Left Ventricular Posterior Wall Thickness at End-Diastole (LVPWd)
Time frame: Baseline
LV posterior wall thickness at end-diastole in active Saudi women, measured in the parasternal long-axis view using AI-assisted handheld POCUS and reported in mm.
Mitral Inflow E/A Ratio
Time frame: Baseline
Ratio of early (E) to late (A) diastolic mitral inflow velocities in active Saudi women, measured by pulsed-wave Doppler in the apical 4-chamber view using AI-assisted handheld POCUS and reported as a unitless ratio.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Active Females and Healthy Adult Female Participants, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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 5 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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 Index (LVMi) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.