MitoQ for High Blood Pressure

(MAVHS Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Auburn University

Must not be taking: Blood thinners

Disqualifiers: Cardiovascular disease, Cancer, Diabetes, Obesity, others

Trial Summary

What is the purpose of this trial?

Black individuals are at increased cardiovascular disease risk. The central goal of the study is to determine if mitochondrial reactive oxygen species influence blood vessel function and nervous system regulation of blood pressure differentially in black, compared to white individuals. These findings may help to explain a potential mechanism that contributes to racial disparities in blood pressure and cardiovascular disease risk. A secondary goal is to determine if mitochondrial reactive oxygen species improves blood pressure and vascular function in individuals with elevated blood pressure and stage 1 hypertension.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is MitoQ safe for humans?

MitoQ has been studied in both animals and humans, showing no significant safety concerns in healthy adults, even at high doses. It has been used in various studies targeting mitochondrial oxidative stress without causing kidney injury or other major side effects. ^{1 2 3 4 5}

How does the drug MitoQ differ from other treatments for high blood pressure?

MitoQ is unique because it targets mitochondria, the energy-producing parts of cells, to reduce oxidative stress, which is a different approach compared to traditional blood pressure medications that often focus on relaxing blood vessels or reducing fluid volume. This novel mechanism may offer benefits for patients with resistant hypertension, where standard treatments are less effective. ^{6 7 8 9 10}

Research Team

Eligibility Criteria

This trial is for black and white individuals aged 19-75 with blood pressure no higher than 150/90 mmHg, a BMI below 35, not currently smoking or having smoked in the past year. They should be free from diabetes, kidney disease, pulmonary disorders, cardiovascular diseases, and must not be on blood thinners or have any issues that prevent exercise.

Inclusion Criteria

Have blood pressure no higher than 150/90 mmHg

My BMI is under 35.

I am between 19 and 75 years old.

Exclusion Criteria

I have a history of heart disease.

Communication barriers

I have a history of kidney disease.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including mental health, sleep quality, physical activity, cardiorespiratory fitness, and dietary intake

1 week

1 visit (in-person)

Treatment

Participants receive acute MitoQ supplementation or placebo, with assessments of sympathetic nerve activity, vascular function, blood pressure, and blood samples before and after supplementation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in flow-mediated dilation, blood biomarkers, muscle sympathetic nerve activity, arterial stiffness, blood pressure reactivity, and reactive oxygen species

1 hour post-supplementation

Treatment Details

Interventions

• MitoQ (Antioxidant)

Trial Overview The study tests if MitoQ affects blood vessel function and nervous system regulation of blood pressure differently across races. It aims to understand racial disparities in hypertension and cardiovascular risk by observing changes in those with elevated blood pressure or stage 1 hypertension.

Participant Groups

Group I: MitoQ Experimental Treatment 1 Intervention

Participants will have sympathetic nerve activity, vascular function, blood pressure and blood samples (from intravenous catheters) assessed before and after acute MitoQ supplementation (80 - 160mg).

Group II: Placebo Placebo Group 1 Intervention

Participants will have sympathetic nerve activity, vascular function, blood pressure and blood samples (from intravenous catheters) assessed before and after a placebo matched in appearance to the MitoQ.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Kinesiology Building Auburn, AL

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Patients Recruited

14,600+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitation and metabolism of mitoquinone, a mitochondria-targeted antioxidant, in rat by liquid chromatography/tandem mass spectrometry. Li, Y., Zhang, H., Fawcett, JP., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transport and metabolism of MitoQ10, a mitochondria-targeted antioxidant, in Caco-2 cell monolayers. Li, Y., Fawcett, JP., Zhang, H., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitochondria-targeted antioxidant MitoQ10 improves endothelial function and attenuates cardiac hypertrophy. Graham, D., Huynh, NN., Hamilton, CA., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute High Dose MitoQ Does not Increase Urinary Kidney Injury Markers in Healthy Adults. Linder, BA., Stute, NL., Hutchison, ZJ., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitoquinol mesylate (MITOQ) attenuates diethyl nitrosamine-induced hepatocellular carcinoma through modulation of mitochondrial antioxidant defense systems. Adisa, RA., Sulaimon, LA., Okeke, EG., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Resistant hypertension : What is it?]. Luft, FC.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence and blood pressure control in patients with primary aldosteronism. Nikrýnová Nguyen, TMP., Štrauch, B., Petrák, O., et al.[2022]

Recent studies highlight the potential of new antihypertensive drugs, such as aprocitentan, baxdrostat, and finerenone, which target specific pathways in resistant hypertension that current treatments do not address, showing promising safety and efficacy.

Catheter-based renal denervation has also been supported as a safe and effective additional treatment for resistant hypertension, providing new options for patients at high cardiovascular risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taming resistant hypertension: The promise of novel pharmacologic approaches and renal denervation. Azzam, O., Nejad, SH., Carnagarin, R., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of resistant arterial hypertension. Shepeleva, NЕ., Rodionov, АV., Fomin, VV.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patiromer to Enable Spironolactone Use in the Treatment of Patients with Resistant Hypertension and Chronic Kidney Disease: Rationale and Design of the AMBER Study. Agarwal, R., Rossignol, P., Garza, D., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Quantitation and metabolism of mitoquinone, a mitochondria-targeted antioxidant, in rat by liquid chromatography/tandem mass spectrometry. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Transport and metabolism of MitoQ10, a mitochondria-targeted antioxidant, in Caco-2 cell monolayers. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Mitochondria-targeted antioxidant MitoQ10 improves endothelial function and attenuates cardiac hypertrophy. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Acute High Dose MitoQ Does not Increase Urinary Kidney Injury Markers in Healthy Adults. [2023]

5. Singapore pubmed.ncbi.nlm.nih.gov

Mitoquinol mesylate (MITOQ) attenuates diethyl nitrosamine-induced hepatocellular carcinoma through modulation of mitochondrial antioxidant defense systems. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

[Resistant hypertension : What is it?]. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Adherence and blood pressure control in patients with primary aldosteronism. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Taming resistant hypertension: The promise of novel pharmacologic approaches and renal denervation. [2023]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of resistant arterial hypertension. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Patiromer to Enable Spironolactone Use in the Treatment of Patients with Resistant Hypertension and Chronic Kidney Disease: Rationale and Design of the AMBER Study. [2022]