What side effects are associated with this type of intervention?

Common treatments for high blood pressure include ACE inhibitors, beta-blockers, calcium channel blockers, diuretics, and angiotensin II receptor blockers (ARBs). ACE inhibitors can cause cough, elevated blood potassium levels, and angioedema. Beta-blockers may lead to fatigue, cold extremities, and bradycardia. Calcium channel blockers can result in dizziness, headache, and peripheral edema. Diuretics often cause increased urination, electrolyte imbalances, and dehydration. ARBs may lead to dizziness, hyperkalemia, and, less commonly, angioedema. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

FDA-approved treatments for high blood pressure primarily include classes of drugs such as angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), calcium channel blockers, diuretics, and beta-blockers. While the provided context does not mention specific FDA approvals related to ER stress modulation for high blood pressure, it does highlight the potential role of endoplasmic reticulum stress in hypertension. Current research is exploring this pathway, but no specific ER stress modulators have been approved by the FDA for treating high blood pressure as of now.

What other types of research exist?

Promising novel alternatives to ER stress modulators for high blood pressure treatment in 2024 include: 1) SGLT2 inhibitors, which have shown cardiovascular benefits and blood pressure reduction in clinical trials; 2) Mineralocorticoid receptor antagonists like finerenone, which have demonstrated efficacy in reducing blood pressure and improving cardiovascular outcomes; 3) Dual endothelin receptor antagonists, which target the endothelin pathway involved in vascular tone and blood pressure regulation; and 4) Novel antihypertensive peptides and small molecules targeting specific pathways involved in blood pressure regulation, such as the natriuretic peptide system.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1-2 weeks before and after intervention or placebo

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

0 / 24Eligibility criteria met

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.