Contributions to Hypertension With Androgen Deprivation Therapy

Launched by UNIVERSITY OF COLORADO, DENVER · Jan 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how androgen deprivation therapy (ADT), a common treatment for prostate cancer, might lead to high blood pressure in men. Prostate cancer affects many men, and while ADT is effective for treatment, it can also increase the risk of heart-related issues, including hypertension (high blood pressure). The researchers want to find out if problems with the nervous system or kidneys, which help control blood pressure, contribute to this risk. Understanding these factors could help develop better treatments to protect heart health in men who have survived prostate cancer.

To participate in the study, men aged 40 and older who have a resting blood pressure below 140/90 mmHg and meet several other health criteria may be eligible. Participants will be asked to undergo some medical evaluations and will need to stop certain medications or supplements before starting the study. Those who qualify will help researchers gather important information about the effects of ADT on blood pressure and overall heart health. This study is currently recruiting participants, and it's a great opportunity for eligible men to contribute to important research that could benefit many others in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • -age 40+ years;
• • resting blood pressure \<140/90 mmHg;
• • fasted blood glucose \<126 mg/dL;
• • testosterone ≥400 ng/dL;
• • sedentary to recreationally active;
• • nonsmokers;
• • healthy as determined by medical history, physical exam, blood and urine chemistries and resting and exercise ECG during a physician supervised graded exercise treadmill test OR recent diagnosis of non-metastatic prostate cancer with plans to undergo androgen deprivation therapy;
• • PSA \<4.00 ng/dL if in the non-cancer group;
• • Gleason Score ≤7 if in the prostate cancer group;
• • no use of medications that might influence cardiovascular function (e.g., antihypertensives, lipid-lowering medications);
• • willing and able to be on GnRHagonist and AR inhibitor;
• • not taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications, or willing to stop use for four weeks prior to the start of the study;
• • not using exogenous sex hormones for at least one year
• Exclusion Criteria:
• • -acute liver disease;
• • chronic kidney disease, serum creatinine \>1.3 mg/dL, macroalbuminuria \>300 mg/g of proteinuria
• • pre-existing or active cardiac, renal or hepatic disease, epilepsy or other seizure disorder;
• • diabetes, active or chronic infection, disease that affects the nervous system;
• • Gleason Score ≥8;
• • thyroid dysfunction, defined as ultrasensitive TSH \<0.5 or \>5.0 mU/L, volunteers with abnormal TSH values will be re-considered for participation after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement;
• • tobacco use within the previous 12 months