MitoQ to Improve Vascular Funciton in Preeclampsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorMedical College of Wisconsin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mitoquinol Mesylate
Dietary supplementPatients randomized to the intervention will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.
Placebo
Other interventionPatients randomized to the placebo groups will take 1 placebo capsule daily until delivery.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Preeclampsia with Severe Features taking Mitoquinol MesylateExperimental treatment 1 intervention
Group B: Preeclampsia with Severe Features taking placeboPlacebo comparator 1 intervention
Group C: Preeclampsia without Severe Features or Gestational Hypertension taking MitoQExperimental treatment 1 intervention
Group D: Preeclampsia without Severe Features or Gestational Hypertension taking placeboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
1-2 times per week from enrollment until delivery, up to 10 monthsSecondary outcomes
1
Cutaneous Microvascular Function
Laser Doppler Flowmetry (LDF) will measure blood flow flux during local skin heating to examine microvessel vasodilation
Time frame
1-2 times per week From enrollment until delivery, up to to months.2
Placental Microvascular Function
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.
Time frame
At Delivery3
Time from Enrollment to Delivery
Time from diagnosis and initiation of MitoQ or placebo to delivery
Time frame
Time in days from enrollment to delivery, up to 10 months4
Blood Draw
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.
Time frame
Weekly from enrollment until Delivery, up to 10 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical College of Wisconsin
Lead sponsor
Bill and Melinda Gates Foundation
Collaborator
Source ClinicalTrials.gov