Cardiovascular Risk Reduction Clinical Trial
Official title:
Impact of Individualized Estrogen Therapy on Cardiovascular Disease Risk Parameters in Young Women After Bilateral Oophorectomy: A Randomized Controlled Trial
Verified date | September 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Researchers are trying to assess the appropriate dose of estrogen for decreasing the risk of cardiovascular disease in women who have removal of their ovaries at a young age, before the age of 46 years.
Status | Completed |
Enrollment | 47 |
Est. completion date | August 28, 2023 |
Est. primary completion date | August 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 45 Years |
Eligibility | Inclusion Criteria: - Premenopausal women undergoing (or completion of a) bilateral oophorectomy for non-malignant diagnoses at Mayo Clinic, Rochester; or premenopausal women not undergoing the procedure for the timed control group - Currently between the ages of 21- 45 years - Able to participate fully in all aspects of the study - Able to understand and sign the informed consent. Exclusion Criteria: - History of hepatic, renal, or hematological diseases - History of venous thromboembolism; peripheral vascular disease; coronary artery disease; stroke/neurovascular disease - Chemotherapy or radiation therapy in the preceding 3 months - Current tobacco use - Current use of medication that alters autonomic or vascular function (e.g. tricyclic antidepressants, a-blockers, ß-blockers, etc.) or aromatase inhibitor/tamoxifen therapy - Contra-indication to estrogen use - Current or previous diagnosis of breast and endometrial cancer - For Timed Controls: Are currently pregnant or lactating, or are of child-bearing potential or are likely to become pregnant during the study and unwilling to use contraception; Acceptable forms include:Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm), Copper Intra Uterine Device, Hysterectomy, Tubal ligation, Abstinence (no sex) - Any condition or factor judged by the investigator to preclude participation in the study |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Endothelial function | Brachial artery flow mediated dilation using ultrasonography to measure any endothelium dysfunction occurring over 12 months. | Baseline, 6 months, and 12 months | |
Primary | Change in cerebral vascular reactivity | Changes to the middle cerebral artery blood flow velocity measured using a Multigon Trans-Cranial Doppler sonogram probe monitoring with three stepwise end-tidal carbon dioxide elevations of constant concentration levels with 3 minutes at each level is compared over planned time frames. | Baseline, 6 months, and 12 months | |
Secondary | Change in Arterial tonometry | Arterial stiffness is recorded through high-fidelity pressure waveforms and compared at planned time frames | Baseline, 6 months, and 12 months | |
Secondary | Changes in maximal Voluntary Contraction of the non-dominant arm | Isometric handgrip exercise squeezing a transducer with goal of consistently maintaining a moderate workload average over 5 attempts and compared over time. | Baseline, 6 months, and 12 months | |
Secondary | Changes to the index of baroreflex sensitivity | Colder pressor test immersing hand up to wrist in ice water while changes in blood pressure and heart rate are monitored and compared over time frames. | Baseline, 6 months, and 12 months | |
Secondary | Changes in measurements of whole body and regional fat and fat-free mass | Measurements will be taken using Dual energy x-ray absorptiometry (DXA) scans and compared over time and between the groups. | Baseline and 12 months |
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Completed |
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