Status:
RECRUITING
Sex Differences in Myocardial Steatosis Induced Left Ventricular Dysfunction
Lead Sponsor:
The University of Texas at Arlington
Collaborating Sponsors:
University of Texas Southwestern Medical Center
Conditions:
Heart Diseases
Left Ventricular Dysfunction
Eligibility:
All Genders
18-30 years
Phase:
PHASE4
Brief Summary
To test the specific research questions, healthy men and age-matched healthy premenopausal females will be enrolled. Subjects will undergo cardiac magnetic resonance imaging and spectroscopy (MRI/MRS)...
Eligibility Criteria
Inclusion
- 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
- Women will be excluded with
- history of or active estrogen-dependent neoplasms, acute liver or gallbladder disease, vaginal bleeding, venous thromboembolism, hypertriglyceridemia, and CVD
- known allergy to transdermal patch, GnRHant (i.e., hypersensitivity to cetrorelix, extrinsic peptide hormones, mannitol, GnRH, benzyl alcohol - the vehicle for injection of cetrorelix)
- history of stomach ulcer or bleeding
- 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).
Key Trial Info
Start Date :
September 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04671966
Start Date
September 13 2018
End Date
December 1 2024
Last Update
February 20 2024
Active Locations (1)
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1
University of Texas at Arlington
Arlington, Texas, United States, 76019