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New treatment option for Hypertension
Official title Targeting Endoplasmic Reticulum Stress in Human Hypertension
ClinicalTrials.gov ID: NCT06025630
What this study is testing
What is TUDCA?
TUDCA is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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);
- Females only: documentation of a negative pregnancy test prior to the familiarization and experimental sessions unless post-menopausal
- 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)
- people who weigh less than 80 lbs.
- Use of prescription drugs, non-prescription drugs, dietary supplements or herbal medicines known to alter vascular function unless cleared prior to the study
- Use of beta blockers
- Daily use of bronchodilators
- Use of anti-coagulant therapy
- Implanted medical devices (e.g. cardiac pacemaker)
- Current or past history of hyperthyroidism, or other thyroid hormone-related disease
- Current use of hormone replacement therapy (e.g., estrogen, testosterone)
- HbA1c \>5.6
- Resting systolic blood pressure of \ 140mmHg or diastolic blood pressure \>90mmHg
- Abnormal 12-lead ECG or uncontrolled heart rhythm issues causing symptoms, or an unstable blood pressure
- History of cerebrovascular abnormalities (e.g., prior stroke, transient ischemic attacks, epilepsy)
- Known history of atherosclerosis of the carotid arteries (i.e., plaque formation)
- History of concussion and or other loss of consciousness within the preceding 30 days
- Autonomic dysfunction (e.g., Shy-Drager Syndrome, Bradbury-Eggleston syndrome, sinus arrhythmia, idiopathic orthostatic hypotension, fainting disorder)
- Respiratory illnesses (e.g., chronic asthma (including exercise-induced asthma), Chronic Obstructive Pulmonary Disease, Reactive Airway Disease)
- Any prior history of anaphylaxis, not just prior reactions to the materials used in this study
- Severe phobia of needles
- Latex allergy aa) Known allergies or sensitivities to substances used in the study (e.g., Lidocaine HCL, sodium nitroprusside, acetylcholine, phentolamine, L-NAME, TUDCA, or related drugs) bb) Donated blood within the...
The study team makes the final eligibility decision.
Where it's taking place
- Fort Worth, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Worth, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.