UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
NCT Number: NCT05700903
This study plans to learn more about contributors to high blood pressure in men who undergo androgen deprivation therapy (ADT) to treat prostate cancer. Prostate cancer is the most common non-skin cancer in men, affecting approximately 1 in 8 American men and its primary treatment is through the use of ADT. However, ADT increases the likelihood of developing heart disease including high blood pressure. This study will determine if dysfunction of the nervous system and/or kidneys occurs in men undergoing ADT, as these systems play a significant role in control of blood pressure. The results from this study will help us understand the ways in which ADT contributes to heart disease and help us develop therapies to prevent heart disease in prostate cancer survivors.
Looking for future studies?
Notify Me40 year and older
Male
Interventional
Phase 4
Aurora, Colorado, 80045, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
8 weeks of GnRH agonist
Other names: Leuprolide, Goserelin
2 weeks of AR Inhibitor
Other names: Bicalutamide, Flutamide, Enzalutamide
Placebo tablet and injection
Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo
The change in cardiovagal baroreflex sensitivity will be assessed the modified Oxford procedure
Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo
The change in blood pressure will be assessed from quiet rest to sympathetic activation using the cold pressor test
Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo
The change in blood pressure will be assessed from quiet rest to isometric handgrip exercise
Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo
Ambulatory blood pressure variability will be determined from 24-hour ambulatory blood pressure monitoring.
Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo
Beat-to-beat blood pressure variability will be using finger photoplethysmography measured in the laboratory.
Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo
Renal blood flow will be determined using ultrasound and blood pressure will be determined using finger photoplethysmography. These measures will be used to estimate renal vascular resistance.
Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo
Neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule (KIM)-1, interleukin (IL)-18, and vanin-1 will be quantified in urine using commercially available assay kits. Concentrations will be normalized to urinary flow rate.
Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo
Changes in muscle sympathetic nerve activity in response to changes in blood pressure will be assessed using the modified Oxford procedure
Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo
The change in muscle sympathetic nerve activity will be assessed from quiet rest to sympathetic activation using the cold pressor test.
Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo
Glomerular filtration rate and renal plasma flow will be calculated by iohexol (Omnipaque 300, GE Healthcare) clearance technique. Plasma and urine iohexol and p-aminohippurate clearance will be measured on a High-Performance Liquid Chromatography (HPLC, Waters, Milford, MA).
Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo
Renal plasma flow will be calculated by p-aminohippurate (Basic Pharma) clearance techniques. Plasma and urine p-aminohippurate clearance will be measured on a High-Performance Liquid Chromatography (HPLC, Waters, Milford, MA).
Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo
Proteomic analysis of inflammatory cascade proteins will be quantified in plasma samples.
Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo
Whole blood reactive oxygen species will be measured in from venous blood samples using electron paramagnetic resonance spectroscopy
Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo
Descriptive variable total body fat mass (for screening and to document any changes with the intervention)
University of Colorado, Denver
Other
Autonomic and Renal Contributions to Hypertension With Androgen Deprivation Therapy
Acronym: ARCH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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