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TUDCA for High Blood Pressure

Phase 1 & 2
Recruiting
Research Sponsored by University of North Texas Health Science Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 to 80 years of age
No tobacco/nicotine use within preceding 6 months (e.g., cigarettes, chewing tobacco, nicotine gum or patches)
Must not have
Subjects who weigh less than 80 lbs.
Use of beta blockers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1-2 weeks before and after intervention or placebo

Summary

This trial tests if TUDCA, a substance that reduces cell stress, can lower blood pressure in people with slightly high or stage 1 high blood pressure. By reducing cell stress, TUDCA may help lower harmful substances that raise blood pressure and damage blood vessels.

Who is the study for?
This trial is for adults aged 18-80 with high blood pressure who are non-smokers, not pregnant, and have a BMI under 35. They must have normal heart health as shown by an ECG and cannot be on certain medications like beta blockers or blood thinners. People with serious health issues such as uncontrolled heart rhythm problems, recent concussions, drug abuse history, cancer, severe allergies including latex or needle phobia are excluded.
What is being tested?
The study tests TUDCA (a compound thought to reduce stress in cells) against a placebo to see if it can help manage hypertension in humans. Participants won't know which they're receiving in this single-blind setup where the researchers but not the subjects know what treatment is being given.
What are the potential side effects?
While specific side effects of TUDCA aren't listed here, common ones may include digestive discomforts like nausea or diarrhea. Placebos typically don't cause side effects but some individuals might experience symptoms due to their expectations of the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I haven't used tobacco or nicotine products in the last 6 months.
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I am a woman and have a negative pregnancy test or am post-menopausal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I weigh less than 80 lbs.
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I am currently taking beta blockers.
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I use bronchodilators every day.
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I have or had a thyroid condition, including hyperthyroidism.
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I have plaque buildup in my carotid arteries.
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I have a condition that affects my body's automatic functions, like blood pressure or heart rate.
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I or my family have a history of blood clots in the legs, pelvis, or lungs.
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I am currently diagnosed with cancer.
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I have had heart surgery or a heart event like a heart attack.
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I am currently using hormone replacement therapy.
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I am not allergic to any drugs used in this study.
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I have a chronic respiratory condition like asthma or COPD.
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I do not currently have a fever over 99.5°F (37.5°C).
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I have had a stroke, mini-stroke, or epilepsy in the past.
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I have heart rhythm problems or unstable blood pressure.
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I have been diagnosed with a neurological disease or cognitive issue.
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I do not meet the age requirement for the trial.
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I am currently breastfeeding.
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I have been diagnosed with anemia.
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I use a long-term hormonal contraceptive like NuvaRing, Depo Provera, or Nexplanon.
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I have had a mastectomy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1-2 weeks before and after intervention or placebo
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1-2 weeks before and after intervention or placebo for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
24 hour Blood Pressure
Secondary study objectives
Arterial Pulse Wave Velocity
Cardiac output
Endoplasmic Reticulum Stress
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Endoplasmic Reticulum Stress InhibitionExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for high blood pressure include ACE inhibitors, which block the conversion of angiotensin I to angiotensin II, reducing vasoconstriction; beta-blockers, which decrease heart rate and cardiac output; calcium channel blockers, which relax blood vessels by inhibiting calcium ion influx; and diuretics, which reduce blood volume by increasing urine output. These mechanisms are crucial for managing high blood pressure as they directly target the physiological pathways that contribute to elevated blood pressure, thereby reducing the risk of cardiovascular events. Emerging treatments, such as ER stress modulators, aim to address hypertension by targeting cellular stress pathways, potentially offering new therapeutic avenues for patients who do not respond to traditional therapies.
Targeting Ouabain- and Adducin-dependent mechanisms of hypertension and cardiovascular remodeling as a novel pharmacological approach.The effects of anti-hypertensive therapy on the structural, mechanical and metabolic properties of the rat aorta.

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Who is running the clinical trial?

University of North Texas Health Science CenterLead Sponsor
40 Previous Clinical Trials
20,698 Total Patients Enrolled
~47 spots leftby Dec 2028
Unbiased ResultsWe believe in providing patients with all the options.
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