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RecruitingNCT07848828ARCHUpdated Sep 30, 2026

Autonomic and Renal Contributions to Hypertension With ADT

A Phase 4 interventional study of Gonadotropin Releasing Hormone Agonists (GNRH) and Androgen receptor (AR) inhibitor in Androgen Deprivation Therapy, Prostate Cancer and Hypertension, sponsored by Virginia Commonwealth University. Recruiting at 1 site in United States. Open to male participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Virginia Commonwealth University · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
40 Years and older
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Androgen Deprivation Therapy
  • Prostate Cancer
  • Hypertension
  • Autonomic Dysfunction
  • Renal Disease
03

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Prostate Cancer

    Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer

    Drug: Gonadotropin Releasing Hormone Agonists (GNRH) · Drug: Androgen receptor (AR) inhibitor

  • Active comparator
    Healthy + ADT

    Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks

    Drug: Gonadotropin Releasing Hormone Agonists (GNRH) · Drug: Androgen receptor (AR) inhibitor

  • Placebo comparator
    Healthy + Placebo

    Healthy men undergoing placebo for 9 weeks.

    Drug: Placebo

Interventions

  • DrugGonadotropin Releasing Hormone Agonists (GNRH)

    8 weeks of GnRH agonist

    Also known as: Leuprolide

  • DrugAndrogen receptor (AR) inhibitor

    2 weeks of AR inhibitor

    Also known as: Bicalutamide, Flutamide

  • DrugPlacebo

    Placebo tablet and injection

05

What researchers measure

Primary outcomes

  1. Change in cardiovagal baroreflex sensitivity

    The change in cardiovagal baroreflex sensitivity will be assessed via the sequence method

    Time frame: Before and after 9 weeks of ADT or placebo

  2. Change in blood pressure reactivity to the cold pressor test

    The change in systolic 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

  3. Change in exercise pressor reflex

    The change in systolic 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

  4. Change in ambulatory blood pressure variability

    Ambulatory systolic blood pressure variability will be determined from 24-hour ambulatory blood pressure monitoring using the standard deviation of blood pressure readings

    Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo

  5. Change in beat-to-beat blood pressure variability

    Beat-to-beat systolic blood pressure variability will be determined using the standard deviation of blood pressure readings from finger photoplethysmography measured in the laboratory.

    Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo

  6. Change in renal vascular resistance

    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

  7. Change in kidney injury biomarkers

    Neutrophil gelatinase-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases 2 (TIMP2), and insulin-like growth factor binding protein 7 (IGFBP7) 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

06

Study locations

1 of 1 sites recruiting
  • Virginia Commonwealth University
    Richmond, Virginia 23220, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07848828
Lead sponsor
Virginia Commonwealth University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Sep 30, 2026
Start date
Aug 1, 2026
Primary completion
Jul 2028 (estimated)
Completion
Jul 2030 (estimated)
Last update
Sep 30, 2026

Study contacts

Matthew Babcock, PhD
Contact
babcockmc@vcu.edu
‪(804) 396-4718‬
Matthew Babcock, PhD
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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