MitoQ to Improve Vascular Funciton in Preeclampsia (MAVEN)

April 27, 2026 updated by: Jennifer McIntosh, Medical College of Wisconsin

MitoQ (Mitoquinol Mesylate) to Ameliorate Vascular Function in Preeclampsia: a Novel Approach

Preeclampsia is a leading cause of maternal and neonatal morbidity and mortality. There is a lack of effective therapeutics for prevention or treatment. Our previous ex vivo work demonstrated that mitochondrial-antioxidants can reverse placental microvascular damage. Therefore, this study will evaluate whether MitoQ (Mitoquinol Mesylate, a mitochondrial-antioxidant) has the potential to restore vasodilation, improve placental function, and therefore promote pregnancy prolongation in patients with preeclampsia. This evaluation of clinical data, patient samples, and vascular function studies in patients with preeclampsia could translate into a viable therapeutic option.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Preeclampsia (PreE) impacts ~10% of pregnancies and has severe outcomes both during and after pregnancy. It is a leading cause of pregnancy-related deaths, and has long term cardiovascular consequences for maternal and child health. Despite advances in the understanding of preeclampsia over the past 50 years, the underlying unifying mechanism causing preeclampsia remains elusive. This critical gap not only encompasses lack of understanding of the pathophysiology, but it also includes a lack of therapeutics for prevention or treatment. Success in this study could translate into a clinical trial that could finally offer a treatment for PreE.

The investigators have recently demonstrated that endothelial function in the human placental microcirculation is impacted by excess reactive oxygen and nitrogen species (ROS, RNS) from the mitochondria (MT), which in preeclampsia, impairs vasodilation. Excess ROS causes decreased nitric oxide (NO) bioavailability, increased lipid peroxidation, uncoupled eNOS, peroxynitrite, and exacerbates MT dysfunction and MT DNA damage via alterations in NO. Microvascular function can be improved by mechanisms that rebalance the oxidative stress response. The investigators have shown that MitoTempol, a MT antioxidant, improves vasodilation. Moreover, the investigators have shown that a major part of the cycle of excessive oxidative stress is caused by MT DNA damage and subsequent activation of toll like receptor 9 (TLR9), and that inhibiting TLR9 prevents this dysfunction. The finding that MT antioxidants given ex-vivo can reverse placental vascular damage after delivery gives promise that treatment of patients during pregnancy could restore vasodilation and allow for safer prolongation of pregnancy.

MitoQ (Mitoquinol Mesylate) is a nutritional supplement, and mitochondrial antioxidant. MitoQ has been extensively studied pre- clinically in cell-culture, and pregnant mouse, rat, and sheep models of PreE or oxidative stress and demonstrated beneficial fetal results. It has been used in clinical trials for heart failure, hepatitis C, Parkinson's, and multiple sclerosis with doses from 10mg to 80mg per day.

Overall Hypothesis: The investigators hypothesize that MitoQ (Mitoquinol Mesylate)-treated preeclampsia patients will have improved brachial artery flow-mediated dilation (FMD) and laser Doppler flowmetry assessments of the cutaneous microvasculature, and that placental endothelial function in micro-vessels and placental pathology will be improved in treated patients. To demonstrate this, the investigators will enroll two pilot human cohorts- one of admitted patients with preeclampsia with severe features who will either continue standard in-patient clinical care or be supplemented daily with MitoQ (Mitoquinol Mesylate) and a second outpatient cohort of patients with preeclampsia without severe features who will received standard outpatient care or be supplemented daily with MitoQ

Aim: Test whether with MitoQ (Mitoquinol Mesylate) treatment in preeclamptic patients improves endothelial function Hypothesis: MitoQ (Mitoquinol Mesylate)-treated patients will have improved brachial artery FMD and laser Doppler flowmetry assessments of the cutaneous microvasculature and placental endothelial function in micro-vessels and placental pathology will be improved in treated patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jennifer McIntosh, D.O., M.S.
  • Phone Number: 14148059019
  • Email: jmcintosh@mcw.edu

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert & the Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inpatient Cohort

    • pregnant patients with a clinical diagnosis of preeclampsia with severe features
    • gestational age between 23+0 and 32+0 weeks' gestation
    • singleton pregnancy
    • age 18-50 years old
    • No indication for immediate delivery (e.g. the patient and their physician team have planned expectant management of preeclampsia with severe features
    • Able to consent and follow a 2-step commend
    • English speaking

  • Outpatient Cohort

    • Pregnant patients with a clinical diagnosis of preeclampsia without severe features
    • gestational age between 23+0 and 34+0 weeks' gestation
    • singleton pregnancy
    • age 18-50 years old
    • No indication for immediate delivery
    • Planned outpatient management of preeclampsia
    • Able to consent and follow a 2-step commend
    • English speaking

Exclusion Criteria:

  • • Unable to stand from chair without physical assistance from another person (able to use assistive device).

    • History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (i.e., wounds in the leg).
    • Chronic lasting symptoms (> 6 months) of severe COVID-19 (i.e., hospitalization)
    • History of head trauma or concussion within the past 6 months
    • Comorbid neurological disorder
    • Peripheral vascular disease
    • Diagnosed myocardial infarction or arrhythmia in the previous year
    • Resting SBP ≥180 mmHg or DBP ≥ 100 mmHg
    • Other significant medical condition likely to influence study or jeopardize safety as assessed by the Primary Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Preeclampsia with Severe Features taking Mitoquinol Mesylate
Patients allocated to this arm will be inpatients who have preeclampsia with severe features. They will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.
Dietary supplement: Mitoquinol Mesylate
Patients randomized to the intervention will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.
Placebo Comparator: Preeclampsia with Severe Features taking placebo
Patients allocated to this arm will be inpatients who have preeclampsia with severe features. They will receive Placebo daily from enrollment until delivery.
Other: Placebo
Patients randomized to the placebo groups will take 1 placebo capsule daily until delivery.
Experimental: Preeclampsia without Severe Features taking MitoQ
Patients allocated to this arm will be out-patients who have preeclampsia without severe features. They will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.
Dietary supplement: Mitoquinol Mesylate
Patients randomized to the intervention will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.
Placebo Comparator: Preeclampsia without Severe Features taking placebo
Patients allocated to this arm will be out-patients who have preeclampsia without severe features. They will receive placebo daily from enrollment until delivery.
Other: Placebo
Patients randomized to the placebo groups will take 1 placebo capsule daily until delivery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brachial Artery Flow Mediated Dilation (FMD)
Time Frame: 1-2 times per week from enrollment until delivery, up to 10 months
We will measure brachial artery vascular health in the arm. Baseline brachial artery diameter and blood flow velocity through the artery will be measured before and after a pneumatic forearm cuff is inflated to 225 mmHg for five minutes.
1-2 times per week from enrollment until delivery, up to 10 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cutaneous Microvascular Function
Time Frame: 1-2 times per week From enrollment until delivery, up to to months.
Laser Doppler Flowmetry (LDF) will measure blood flow flux during local skin heating to examine microvessel vasodilation
1-2 times per week From enrollment until delivery, up to to months.
Placental Microvascular Function
Time Frame: At Delivery
After delivery, placental vessels will be isolated from the placenta and a videomicroscopy technique will be used to evaluate flow-mediated dilation in vessels from placebo and MitoQ treated pregnancies.
At Delivery
Time from Enrollment to Delivery
Time Frame: Time in days from enrollment to delivery, up to 10 months
Time from diagnosis and initiation of MitoQ or placebo to delivery
Time in days from enrollment to delivery, up to 10 months
Blood Draw
Time Frame: Weekly from enrollment until Delivery, up to 10 months
We will collect blood each week. The blood draw analysis may include but will not be limited to examining sFlt:PlGF ratio, plasma redox and bioenergetic analyses.
Weekly from enrollment until Delivery, up to 10 months
Maternal Preeclampsia Severity
Time Frame: From enrollment until delivery, up to 10 months
A composite outcome of Maternal Severity of preeclampsia will be assessed and include laboratory, blood pressure, and ultrasound data relevant to preeclampsia
From enrollment until delivery, up to 10 months
Composite Neonatal Delivery Outcome
Time Frame: Collected from delivery until hospital discharge; up to 1 week after birth.
A composite outcome of neonatal delivery information including (but not limited to): cord blood, gestational age, weight, APGARs
Collected from delivery until hospital discharge; up to 1 week after birth.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical College of Wisconsin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bill and Melinda Gates Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer J McIntosh, D.O.,, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO00056100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The cleaned, item-level spreadsheet data for all variables will be shared openly, along with example quantifications and transformations from initial raw data. Final files used to generate specific analyses as well as related results will also be shared. The rationale for sharing only cleaned data is to foster ease of data reuse. The final dataset will include clinical data procured from demographic and relevant medical record information from participants. We will share de-identified individual-participant level (IPD) data. Appropriate de-identification measures will be utilized from IRB approved protocols and informed consents.

IPD Sharing Time Frame

Data will be made available 2 years after the completion of the study.

IPD Sharing Access Criteria

Those interested in accessing the data will contact the PI and the study team will review requests and share relevant de-identified individual-participant level (IPD) data .

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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