MitoQ to Improve Vascular Funciton in Preeclampsia

NCT07229261 | Recruiting

• 1 other identifier: PRO00056100
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia; Pregnancy

Keywords

pregnancy; preeclampsia; MitoQ; Mitoquinone; Endothelial Function

Outcome Measures

Primary Outcomes (1)

• Brachial Artery Flow Mediated Dilation (FMD)

  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 Outcomes (6)

• Cutaneous Microvascular Function

  1-2 times per week From enrollment until delivery, up to to months.

• Placental Microvascular Function

  At Delivery

• Time from Enrollment to Delivery

  Time in days from enrollment to delivery, up to 10 months

• Blood Draw

  Weekly from enrollment until Delivery, up to 10 months

• Maternal Preeclampsia Severity

  From enrollment until delivery, up to 10 months

Study Arms (4)

Preeclampsia with Severe Features taking Mitoquinol Mesylate

EXPERIMENTAL

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

Preeclampsia with Severe Features taking placebo

PLACEBO COMPARATOR

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

Preeclampsia without Severe Features taking MitoQ

EXPERIMENTAL

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

Preeclampsia without Severe Features taking placebo

PLACEBO COMPARATOR

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

Interventions

Mitoquinol Mesylate DIETARY_SUPPLEMENT

Patients randomized to the intervention will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.

Preeclampsia with Severe Features taking Mitoquinol Mesylate; Preeclampsia without Severe Features taking MitoQ

Placebo OTHER

Patients randomized to the placebo groups will take 1 placebo capsule daily until delivery.

Preeclampsia with Severe Features taking placebo; Preeclampsia without Severe Features taking placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Only patients who are pregnant are able to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (10)

• Vangrieken P, Al-Nasiry S, Bast A, Leermakers PA, Tulen CBM, Schiffers PMH, van Schooten FJ, Remels AHV. Placental Mitochondrial Abnormalities in Preeclampsia. Reprod Sci. 2021 Aug;28(8):2186-2199. doi: 10.1007/s43032-021-00464-y. Epub 2021 Feb 1.

  PMID: 33523425 BACKGROUND

• Chekir C, Nakatsuka M, Noguchi S, Konishi H, Kamada Y, Sasaki A, Hao L, Hiramatsu Y. Accumulation of advanced glycation end products in women with preeclampsia: possible involvement of placental oxidative and nitrative stress. Placenta. 2006 Feb-Mar;27(2-3):225-33. doi: 10.1016/j.placenta.2005.02.016. Epub 2005 Apr 22.

  PMID: 16338468 BACKGROUND

• Zsengeller ZK, Rajakumar A, Hunter JT, Salahuddin S, Rana S, Stillman IE, Ananth Karumanchi S. Trophoblast mitochondrial function is impaired in preeclampsia and correlates negatively with the expression of soluble fms-like tyrosine kinase 1. Pregnancy Hypertens. 2016 Oct;6(4):313-319. doi: 10.1016/j.preghy.2016.06.004. Epub 2016 Jun 30.

  PMID: 27939475 BACKGROUND

• Opichka MA, Livergood MC, Balapattabi K, Ritter ML, Brozoski DT, Wackman KK, Lu KT, Kozak KN, Wells C, Fogo AB, Gibson-Corley KN, Kwitek AE, Sigmund CD, McIntosh JJ, Grobe JL. Mitochondrial-targeted antioxidant attenuates preeclampsia-like phenotypes induced by syncytiotrophoblast-specific Galphaq signaling. Sci Adv. 2023 Dec;9(48):eadg8118. doi: 10.1126/sciadv.adg8118. Epub 2023 Dec 1.

  PMID: 38039359 BACKGROUND

• Oyewole AO, Birch-Machin MA. Mitochondria-targeted antioxidants. FASEB J. 2015 Dec;29(12):4766-71. doi: 10.1096/fj.15-275404. Epub 2015 Aug 7.

  PMID: 26253366 BACKGROUND

• Vaka R, Deer E, LaMarca B. Is Mitochondrial Oxidative Stress a Viable Therapeutic Target in Preeclampsia? Antioxidants (Basel). 2022 Jan 22;11(2):210. doi: 10.3390/antiox11020210.

  PMID: 35204094 BACKGROUND

• Teran E, Hernandez I, Nieto B, Tavara R, Ocampo JE, Calle A. Coenzyme Q10 supplementation during pregnancy reduces the risk of pre-eclampsia. Int J Gynaecol Obstet. 2009 Apr;105(1):43-5. doi: 10.1016/j.ijgo.2008.11.033. Epub 2009 Jan 19.

  PMID: 19154996 BACKGROUND

• Weissgerber TL, Milic NM, Milin-Lazovic JS, Garovic VD. Impaired Flow-Mediated Dilation Before, During, and After Preeclampsia: A Systematic Review and Meta-Analysis. Hypertension. 2016 Feb;67(2):415-23. doi: 10.1161/HYPERTENSIONAHA.115.06554. Epub 2015 Dec 28.

  PMID: 26711737 BACKGROUND

• Stanhewicz AE, Nuckols VR, Pierce GL. Maternal microvascular dysfunction during preeclamptic pregnancy. Clin Sci (Lond). 2021 May 14;135(9):1083-1101. doi: 10.1042/CS20200894.

  PMID: 33960392 BACKGROUND

• Sanchez-Aranguren LC, Prada CE, Riano-Medina CE, Lopez M. Endothelial dysfunction and preeclampsia: role of oxidative stress. Front Physiol. 2014 Oct 10;5:372. doi: 10.3389/fphys.2014.00372. eCollection 2014.

  PMID: 25346691 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jennifer J McIntosh, D.O.,

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer McIntosh, D.O., M.S.

CONTACT

14148059019; jmcintosh@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: March 18, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available 2 years after the completion of the study.
• 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 .

Locations

US (1)