Targeting Endoplasmic Reticulum Stress in Human Hypertension (NCT06025630) | Clinical Trial Compass
RecruitingPhase 1/2
Targeting Endoplasmic Reticulum Stress in Human Hypertension
United States70 participantsStarted 2023-08-15
Plain-language summary
There is strong evidence suggesting that endoplasmic reticulum stress contributes to neurogenic and vascular hypertension in various animal models, however this has never been explored in humans. Therefore, this project will fill this gap by performing a single-blind, placebo-controlled trial in humans with hypertension.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 to 80 years of age
. No tobacco/nicotine use within preceding 6 months (e.g., cigarettes, chewing tobacco, nicotine gum or patches)
. Systolic blood pressure \<140 mmHg; diastolic blood pressure \<90 mmHg (obtained at the Screening and Familiarization Visit)
. Normal 12-lead ECG (obtained at the Screening and Familiarization Visit and reviewed by a board-certified physician)
. Normal clinical results from a medical exam reviewed by a board-certified physician (e.g., General Health Questionnaire obtained at the Screening and Familiarization Visit)
. Body mass index (BMI) \<35 unless athletic/muscular build; calculation = body weight (kg)/height (m2);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
24 hour Blood Pressure
Timeframe: Within 1-2 weeks before and after intervention or placebo
Trial details
NCT IDNCT06025630
SponsorUniversity of North Texas Health Science Center
. Females only: documentation of a negative pregnancy test prior to the familiarization and experimental sessions unless post-menopausal
Exclusion criteria
. Not meeting the defined age criteria
. Body mass index (BMI) \>35 unless athletic/muscular build; calculation = body weight (kg)/height (m2)
. Any tobacco/nicotine use within the last 6 months (e.g., cigarettes, chewing tobacco, nicotine gum or patches)
. Positive pregnancy test
. Females with an erratic/irregular menstrual cycle
. Females who are breastfeeding
. Women who are prescribed a continually releasing hormonal contraceptive (e.g. NuvaRingTM or other hormone releasing vaginal rings, Depo Provera shot, or birth control implants such as Nexplanon)