TUDCA for High Blood Pressure

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of North Texas Health Science Center

Must not be taking: Beta blockers, Bronchodilators, Anticoagulants, others

Disqualifiers: Tobacco use, Pregnancy, Hyperthyroidism, others

Compensation: Varies

Number of Visits: 2

Duration: 4-8 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with high blood pressure (hypertension). Researchers believe stress in the endoplasmic reticulum may contribute to hypertension. Participants will receive either a placebo (a harmless pill with no effect) or TUDCA (tauroursodeoxycholic acid), which might help reduce this stress. The trial seeks individuals with blood pressure readings below 140/90 mmHg who have not used tobacco or nicotine products in the past six months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, especially those that alter vascular function, beta blockers, bronchodilators, anti-coagulants, hormone replacement therapy, and PDE3 inhibitors. If you are on any of these, you may need to stop them before participating, but it's best to discuss with the study team for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that TUDCA has been tested in various studies for safety and effectiveness. In one study involving patients with a different condition, TUDCA was added to their treatment, and researchers found no major safety issues. This suggests TUDCA is generally safe for patients.

Another study examined TUDCA's impact on kidney health and found it helped prevent kidney problems without causing significant side effects. Additionally, the FDA has approved TUDCA for certain liver conditions, indicating its safety when used properly.

Overall, while specific research on using TUDCA for high blood pressure in humans is limited, studies in other areas support its safety. Every treatment can have side effects, so discussing any concerns with a healthcare provider is advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TUDCA for high blood pressure because it works differently from typical treatments like ACE inhibitors or beta-blockers. Most treatments for high blood pressure focus on relaxing blood vessels or reducing heart rate. But TUDCA targets endoplasmic reticulum stress, a unique approach that could address blood pressure regulation at a cellular level. This new mechanism of action offers a promising alternative for patients who may not respond well to conventional therapies.

What evidence suggests that TUDCA might be an effective treatment for high blood pressure?

Research suggests that TUDCA (tauroursodeoxycholic acid), which participants in this trial may receive, may help lower high blood pressure. Studies have shown that TUDCA can reduce blood pressure and ease stress on blood vessels, potentially benefiting those with high blood pressure. Animal studies found that TUDCA can prevent kidney damage caused by a high-salt diet, often linked to high blood pressure. Although researchers have not yet tested it in humans for this specific use, its ability to reduce cell stress shows promise for people with high blood pressure. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a woman and have a negative pregnancy test or am post-menopausal.

Your blood pressure is below 140/90 mmHg.

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)

Exclusion Criteria

I weigh less than 80 lbs.

I am currently taking beta blockers.

I use bronchodilators every day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tauroursodeoxycholic acid or placebo to inhibit endoplasmic reticulum stress

4-8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• TUDCA

Trial Overview 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.

How Is the Trial Designed?

Group I: Endoplasmic Reticulum Stress Inhibition Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of North Texas Health Science Center

Lead Sponsor

Trials

41

Recruited

20,800+

Published Research Related to This Trial

In a study of 199 Chinese patients with primary biliary cholangitis (PBC), tauroursodeoxycholic acid (TUDCA) demonstrated similar efficacy to ursodeoxycholic acid (UDCA) in reducing serum alkaline phosphatase (ALP) levels after 24 weeks of treatment.

TUDCA was found to be safer, as it did not increase the incidence of pruritus (itching), which rose significantly in the UDCA group, indicating that TUDCA may provide symptom relief without the side effects associated with UDCA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter, randomized, double-blind trial comparing the efficacy and safety of TUDCA and UDCA in Chinese patients with primary biliary cholangitis. Ma, H., Zeng, M., Han, Y., et al.[2023]

In a study of 258 ALS patients, those treated with oral tauroursodeoxycholic acid (TUDCA) showed a median overall survival of 49.6 months, compared to 36.2 months for those receiving standard care, suggesting a potential survival benefit from TUDCA treatment.

Higher dosages of TUDCA (≥1000 mg/day) were associated with a significantly reduced risk of death (HR 0.56), and the treatment was generally well-tolerated, with only a small percentage of patients experiencing mild gastrointestinal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of tauroursodeoxycholic acid on survival and safety in amyotrophic lateral sclerosis: a retrospective population-based cohort study. Zucchi, E., Musazzi, UM., Fedele, G., et al.[2023]

Tauroursodeoxycholic acid (TUDCA) shows promise as a treatment for diabetic kidney disease (DKD), particularly when used in combination with telmisartan, an established angiotensin II receptor blocker, based on both in vitro and in vivo studies involving Wistar rats.

The combination therapy of TUDCA and telmisartan was more effective in improving renal function and reducing cell death and fibrosis compared to either treatment alone, suggesting that TUDCA could be a valuable addition to current DKD therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the potential of tauroursodeoxycholic acid as add-on therapy in amelioration of streptozotocin-induced diabetic kidney disease. Sankrityayan, H., Shelke, V., Kale, A., et al.[2023]

In a double-blind randomized trial involving 23 patients with liver cirrhosis, tauroursodeoxycholic acid (TUDCA) showed a significant reduction in serum ALT, AST, and ALP levels compared to baseline, indicating its potential therapeutic efficacy over 6 months.

Both TUDCA and ursodeoxycholic acid (UDCA) were well tolerated with no reported side effects, but TUDCA appeared to be more effective in improving biochemical markers of liver function, although neither treatment significantly affected liver fibrosis markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tauroursodeoxycholic acid in the treatment of liver cirrhosis: a double-blind randomized controlled trial. Pan, XL., Zhao, L., Li, L., et al.[2021]

Tauroursodeoxycholic acid (TUDCA) has shown significant neuroprotective effects in various retinal disorders, including retinitis pigmentosa and diabetic retinopathy, based on a systematic review of 24 studies involving both in vitro and in vivo experiments.

The mechanisms by which TUDCA exerts its protective effects include inhibiting apoptosis, reducing inflammation, alleviating oxidative stress, and suppressing endoplasmic reticulum stress, suggesting it could be a promising therapeutic agent for retinal diseases, although further clinical trials are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotective Effect of Tauroursodeoxycholic Acid (TUDCA) on In Vitro and In Vivo Models of Retinal Disorders: A Systematic Review. Li, J., Huang, Z., Jin, Y., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6462246/

Tauroursodeoxycholic acid (TUDCA) abolishes chronic ... The results demonstrate that TUDCA treatment prevents the development of high salt-induced proteinuria, albuminuria, and renal glomerular and cortical tubular ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4030606/

and Tauroursodeoxycholic Acid in the Treatment of Non-liver ... ... hypertension. It also suppressed proliferation in pulmonary artery smooth muscle cells and reduced the elevated blood pressure. TUDCA injections into the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00877604

Efficacy and Tolerability of Tauroursodeoxycholic Acid in ... This protocol is meant for assessing if the addition of TUDCA to the conventional therapy can improve the therapeutic outcome in patients affected by ALS.

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00433-9/fulltext

Effect of tauroursodeoxycholic acid on survival and safety ... In this population-based exploratory study, patients with ALS who were treated with TUDCA may have prolonged survival compared to patients ...

5. withpower.com withpower.com/trial/phase-2-hypertension-7-2023-70d4b

TUDCA for High Blood Pressure 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10570688/

Effect of tauroursodeoxycholic acid on survival and safety ... The primary outcome was survival difference (time from onset of symptoms to tracheostomy/death) between TUDCA exposed and unexposed patients.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03800524

NCT03800524 | Safety and Efficacy of TUDCA as add-on ... ... TUDCA-ALS Study Group. A randomized double-blind clinical trial on safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients ...

8. examine.com examine.com/supplements/tudca/research/?srsltid=AfmBOorgCQGVCw__nyjaeZCB7ILRaS9RqbiVKnOVnxloxKX2UpEHw8DE

Research Breakdown on TUDCA TUDCA plays a role in maintaining cellular health. It is claimed to have neuroprotective effects and to improve liver health.

9. investors.amylyx.com investors.amylyx.com/news-releases/news-release-details/amylyx-pharmaceuticals-announces-fda-approval-relyvriotm

Amylyx Pharmaceuticals Announces FDA Approval of ... RELYVRIO contains a high amount of salt. For people who are sensitive to salt intake, such as people with heart failure, high blood pressure, or ...