Targeting Endoplasmic Reticulum Stress in Human Hypertension

NCT06025630 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ERX:2023-063
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

high blood pressure; tauroursodeoxycholic acid (TUDCA); endoplasmic reticulum

Outcome Measures

Primary Outcomes (1)

• 24 hour Blood Pressure

  Systolic and diastolic blood pressure will be measured twice per hour during the day and once per hour at night using a portable cuff.

  Within 1-2 weeks before and after intervention or placebo

Secondary Outcomes (4)

• Neurovascular Function

  Within 1-2 weeks before and after intervention or placebo

• Cardiac output

  Within 1-2 weeks before and after intervention or placebo

• Arterial Pulse Wave Velocity

  Within 1-2 weeks before and after intervention or placebo

• Endoplasmic Reticulum Stress

  Within 1-2 weeks before and after intervention or placebo

Study Arms (2)

Endoplasmic Reticulum Stress Inhibition

EXPERIMENTAL

Drug: TUDCA

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TUDCA DRUG

Endoplasmic reticulum stress will be inhibited by chronic (8 weeks) oral ingestion of the dietary supplement tauroursodeoxycholic acid (TUDCA; 1,750 mg/day)

Endoplasmic Reticulum Stress Inhibition

Placebo DRUG

Placebo pills containing microcrystalline cellulose will be ingested over the course of the 8 week intervention.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of North Texas Health Science Center: lead

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

ursodoxicoltaurine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to which condition they are randomly assigned (placebo vs TUDCA ingestion)
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study uses a single-blind, placebo-controlled model.

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 6, 2023
• Study Start: August 15, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)