Health TrialsbyHealthPanel

Autonomic and Renal Contributions to Hypertension With ADT

ConditionsAndrogen Deprivation TherapyProstate CancerHypertensionAutonomic DysfunctionRenal Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age40+
SponsorVirginia Commonwealth University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age 40+ years;

resting blood pressure <140/90 mmHg;

fasted blood glucose <126 mg/dL;

testosterone ≥400 ng/dL;

Disqualifiers

-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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gonadotropin Releasing Hormone Agonists (GNRH)

    Drug

    8 weeks of GnRH agonist

  • Androgen receptor (AR) inhibitor

    Drug

    2 weeks of AR inhibitor

  • Placebo

    Drug

    Placebo tablet and injection

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Prostate CancerActive comparator 2 interventions
Group B: Healthy + ADTActive comparator 2 interventions
Group C: Healthy + PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Commonwealth University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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