Sex Differences in Myocardial Steatosis Induced Left Ventricular Dysfunction
Launched by THE UNIVERSITY OF TEXAS AT ARLINGTON · Dec 11, 2020
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how fat accumulation in the heart affects its function differently in men and women, particularly focusing on premenopausal women. Researchers want to understand whether estrogen, a hormone that women produce, helps protect against heart issues caused by this fat buildup. To do this, they will enroll healthy men and women aged 65 to 74 who do not smoke, have normal blood pressure, and are not on hormone therapy or certain medications. Participants will undergo a series of heart imaging tests after a 48-hour fast, which is designed to temporarily increase fat levels in the heart.
If you join the study, you'll first meet with the research team to ask any questions before giving your consent. You'll be screened to ensure you meet the eligibility criteria and that it's safe for you to participate in an MRI scan. The entire process will take about 90 to 120 minutes, during which you'll have your heart imaged and your blood pressure monitored. This trial will help researchers learn more about heart health and the differences between sexes, which could lead to better treatments for heart diseases in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • blood pressure \<140/90 mmHg
- • BMI between 18.5 and 30 kg/m2
- • sedentary or recreationally active (\<3 days of vigorous aerobic exercise each week)
- • no use of oral contraceptives hormone therapy, or other medications that might influence cardiovascular function
- • nonsmokers.
- Exclusion Criteria:
- • Women will be excluded with
- • 1. history of or active estrogen-dependent neoplasms, acute liver or gallbladder disease, vaginal bleeding, venous thromboembolism, hypertriglyceridemia, and CVD
- • 2. known allergy to transdermal patch, GnRHant (i.e., hypersensitivity to cetrorelix, extrinsic peptide hormones, mannitol, GnRH, benzyl alcohol - the vehicle for injection of cetrorelix)
- • 3. history of stomach ulcer or bleeding
- • 4. other contraindications to hormone replacement therapy or GnRHant, (i.e., taking Levodopa, medications that can inhibit folate metabolism including methotrexate).
- Other conditions for which individuals will be excluded from the study include:
- • diabetes active infection history of seizures or disease that affects the nervous system sepsis an abnormal resting ECG contraindications to MRI pregnant or planning to become pregnant smoking history illicit drug use (excluding occasional marijuana).
About The University Of Texas At Arlington
The University of Texas at Arlington (UTA) is a leading academic institution dedicated to advancing research and innovation across various fields, including health sciences. With a strong commitment to improving public health and clinical outcomes, UTA actively sponsors clinical trials that aim to explore novel therapeutics, enhance patient care, and address pressing health challenges. The university's interdisciplinary approach fosters collaboration among researchers, healthcare professionals, and community stakeholders, ensuring that trials are conducted with rigor and integrity. UTA's state-of-the-art facilities and access to diverse patient populations enable the effective execution of clinical research, contributing to the advancement of medical knowledge and practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Arlington, Texas, United States
Patients applied
Trial Officials
michael nelson, PhD
Principal Investigator
University of Texas at Arlington
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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