RightFit
RecruitingPhase 4

Autonomic and Renal Contributions to Hypertension With ADT

Autonomic and Renal Contributions to Hypertension With Androgen Deprivation Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
Male only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how the nerves and kidneys may lead to high blood pressure in men getting androgen deprivation therapy (ADT), a hormone treatment for prostate cancer. It is for men age 40 or older who are healthy or have newly diagnosed prostate cancer that has not spread and plan to start ADT.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 40 or older, with little exercise or exercise for fun; must not smoke.
  • Resting blood pressure below 140/90 mmHg, blood sugar after fasting below 126 mg/dL, and testosterone at least 400 ng/dL.
  • Healthy based on a medical exam, blood and urine tests, and heart tests at rest and during treadmill exercise; OR recently diagnosed with prostate cancer that has not spread and planning ADT.
  • If you do not have cancer: PSA, a prostate blood test, below 4.00 ng/dL. If you have prostate cancer: Gleason score, a measure of how fast cancer may grow, of 7 or lower.
  • Not taking medicines that may affect the heart or blood vessels, such as blood pressure or cholesterol medicines.
  • Willing and able to take a GnRH agonist and an AR inhibitor, two types of hormone treatment.
  • Not taking antioxidant vitamins, corticosteroids, or medicines for inflammation, or willing to stop them four weeks before the study.
  • No use of sex hormones from outside the body for at least one year.

Who can't join

  • Current or past heart, kidney, or liver disease, including sudden liver disease or long-term kidney disease.
  • Blood creatinine above 1.3 mg/dL or urine protein above 300 mg/g; these tests help check kidney health.
  • Epilepsy or another seizure disorder.
  • Diabetes, a current or long-term infection, or a disease affecting the nerves.
  • Gleason score of 8 or higher, which means the prostate cancer may grow faster.
  • A thyroid blood test (TSH) below 0.5 or above 5.0 mU/L. You may be considered again after your regular doctor checks this and starts or changes thyroid medicine.
  • Tobacco use in the past 12 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

VA