NCT05471518Completed
Sex Hormone and Vascular Function in Women With CKD
Source: ClinicalTrials.gov · Last updated 18 Sept 2025
Brief summary (registry, in English)
The risk of cardiovascular disease (CVD) is significantly elevated in patients with chronic kidney disease (CKD). Notably, women with CKD commonly experience menstrual disturbances induced by CKD, which may contribute to impaired vascular function and elevated CVD risk. However, most of the literature in the field of nephrology focuses on male patients, and studies on women's vascular health are limited. Moreover, endogenous sex hormones, particularly estradiol, are well-documented to be cardioprotective in women without CKD; however, the role of sex hormones on vascular function in women with CKD remains unclear. The goals of the proposed project are: 1) to evaluate vasuclar function in pre- and post-menopausal women with CKD vs. age-matched healthy women; 2) to evaluate sex hormone concentrations and determine whether they associate with vascular function in the proposed cohort; and 3) to gain mechanistic insight on the association between sex hormones and vascular dysfunction in the proposed cohort.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 51 (actual)
- First submitted
- 20 Jul 2022
- Start date
- 1 Jul 2021
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Chronic kidney disease
- NCT number
- NCT05471518
What you commit to
- Study type: Observational
- Participants enrolled: 51
- From 1 Jul 2021 to the primary completion date, 30 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of hormonal birth control methods, hormone replacement therapy, or a levonorgestrel intrauterine device (IUD) insertion for a duration less than 6 months
- Antioxidant and/or omega-3 fatty acid use within the 2 weeks prior to testing
- Marijuana use within 2 weeks prior to testing
Other illness
- History of kidney transplant
- Use of immunosuppressant medications (unless taking a stable dosage for a quiescent disease in CKD group)
- Current tobacco or nicotine use or history of use in the last 12 months
- Uncontrolled hypertension in CKD group (BP \>140/90 mmHg)
- Active infection or antibiotic therapy
Other
- Perimenopausal (45-54 y) women
- Pregnancy, lactation, or less than one year post-partum
- Advanced CKD requiring dialysis
- Atrial fibrillation
- Hospitalization in the last month
Who the study is looking for
- Pre- (18-44 y) and post-menopausal (55-75 y) women
- Individuals with CKD including stage 3-4 (eGFR 15-59 ml/min/1.73m2) determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation AND/OR urinary albumin-creatinine ratio (UACR) ≥ 30.
- Controls must be healthy (free from hypertension, kidney disease, cardiovascular disease, diabetes, and other chronic disease as assessed by self-report, medical history, and screening labs). Premenopausal healthy women must have a regular menstrual cycle (25-35 d).
Age in the registry: 18 years to 75 years · Sex: Female
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.