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MitoQ para Mejorar la Función Vascular en la Preeclampsia (MAVEN)

29 de septiembre de 2026 actualizado por: Jennifer McIntosh, Medical College of Wisconsin

MitoQ (Mesilato de Mitoquinol) para Mejorar la Función Vascular en la Preeclampsia: un Enfoque Novedoso

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 gestational hypertension (gHTN) and/or preeclampsia. This evaluation of clinical data, patient samples, and vascular function studies in patients with gHTN and/or preeclampsia could translate into a viable therapeutic option.

Descripción general del estudio

Estado

Reclutamiento

Descripción detallada

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 and/or gHTN 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 or gHTN who will received standard outpatient care or be supplemented daily with MitoQ

Aim: Test whether with MitoQ (Mitoquinol Mesylate) treatment in gHTN/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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jennifer McIntosh, D.O., M.S.
  • Número de teléfono: 14148059019
  • Correo electrónico: jmcintosh@mcw.edu

Ubicaciones de estudio

    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Reclutamiento
        • Froedtert & the Medical College of Wisconsin
        • Contacto:
          • Jennifer McIntosh
          • Número de teléfono: 4148059019
          • Correo electrónico: jmcintosh@mcw.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 50 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Inpatient Cohort

    • pregnant patients with a clinical diagnosis of preeclampsia with severe features
    • gestational age between 23+0 and 33+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 or gestational hypertension
    • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.

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

Comparador de placebos: 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.

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

Experimental: Preeclampsia without Severe Features or Gestational Hypertension taking MitoQ

Patients allocated to this arm will be out-patients who have gestational hypertension or preeclampsia without severe features. They will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.

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

Comparador de placebos: Preeclampsia without Severe Features or Gestational Hypertension taking placebo

Patients allocated to this arm will be out-patients who have gestational hypertension or preeclampsia without severe features. They will receive placebo daily from enrollment until delivery.

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Brachial Artery Flow Mediated Dilation (FMD)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cutaneous Microvascular Function
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Jennifer J McIntosh, D.O.,, Medical College of Wisconsin

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

18 de marzo de 2026

Finalización primaria (Estimado)

30 de septiembre de 2027

Finalización del estudio (Estimado)

30 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

13 de noviembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

13 de noviembre de 2025

Publicado por primera vez (Actual)

14 de noviembre de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de IPD

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 .

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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