Targeting Endoplasmic Reticulum Stress in Human Hypertension

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT06025630

Run by

University of North Texas Health Science Center

People needed

70

Starts

2023-08-15

Expected to finish

2028-12-31

Last updated by the study team

2025-03-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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

You may not qualify 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
• 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)
• Subjects 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 <100 mmHg; >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

Where it is running

• University of North Texas Health Science Center — Fort Worth, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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