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NCT04273854: POP-HT

Physician Optimised Post-partum Hypertension Treatment Trial

Active, enrolled NA Last updated 22 October 2021
What this trial tests

NA trial testing OMRON Evolv® blood pressure monitor (Blue-tooth® enabled) & Proprietary Smartphone POP-HT app® in Pre-Eclampsia in 200 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
21 February 2020
Primary endpoint
1 April 2022
1 December 2030

Quick facts

Lead sponsorUniversity of Oxford
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment200
Start date21 February 2020
Primary completion1 April 2022
Estimated completion1 December 2030
Sites2 locations across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University of Oxford

Who can join

18 and older, female only, with Pre-Eclampsia or Gestational Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It has been shown in a pilot randomised controlled study \[SNAP-HT \[4\]; REC 14/SC/1316\] that blood pressure self-management during the post-partum period after hypertensive pregnancies, results in lower blood pressure after six months; even when medication has been stopped. The team now want to assess whether this blood pressure reduction can be reproduced in a larger, randomised, study (data analysis blinded) and whether the blood pressure lowering has additional benefits in terms of other cardiovascular and cerebrovascular changes known to occur in women who have had a hypertensive pregnancy. The investigators therefore plan to run a trial of self-management in the post-partum period, using updated Blue-tooth® enabled blood pressure monitoring coupled to physician-assisted dose titration to further advance the self-management aspect of the intervention. The physicians will be specialist clinicians who form part of the research team. The investigators will measure additional structural and functional end organ differences, using magnetic resonance imaging of the brain and heart as well as echocardiography and retinal imaging. This will provide insight into the impact of post-partum blood pressure control on the maternal cardiovascular system and how this associates with blood pressure changes. Together, these studies will help refine future intervention strategies in this cohort of patients.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Short-Term Postpartum Blood Pressure Self-Management and Long-Term Blood Pressure Control: A Randomized Controlled Trial.
    Kitt JA, Fox RL, Cairns AE, Mollison J, et al · · 2021 · cited 81× · PMID 34176288 · DOI 10.1161/hypertensionaha.120.17101
  2. Long-Term Blood Pressure Control After Hypertensive Pregnancy Following Physician-Optimized Self-Management: The POP-HT Randomized Clinical Trial.
    Kitt J, Fox R, Frost A, Shanyinde M, et al · · 2023 · cited 73× · PMID 37950919 · DOI 10.1001/jama.2023.21523
  3. Cardiac Remodeling After Hypertensive Pregnancy Following Physician-Optimized Blood Pressure Self-Management: The POP-HT Randomized Clinical Trial Imaging Substudy.
    Kitt J, Krasner S, Barr L, Frost A, et al · · 2024 · cited 37× · PMID 37950907 · DOI 10.1161/circulationaha.123.067597
  4. Postpartum blood pressure self-management following hypertensive pregnancy: protocol of the Physician Optimised Post-partum Hypertension Treatment (POP-HT) trial.
    Kitt J, Frost A, Mollison J, Tucker KL, et al · · 2022 · cited 16× · PMID 35197335 · DOI 10.1136/bmjopen-2021-051180
  5. Brain Volumes After Hypertensive Pregnancy and Postpartum Blood Pressure Management: A POP-HT Randomized Clinical Trial Imaging Substudy.
    Lapidaire W, Kitt J, Krasner S, Bateman PA, et al · · 2026 · PMID 41490362 · DOI 10.1001/jamaneurol.2025.5145
  6. Impact of Blood Pressure Self-Management on Vascular Remodeling After Hypertensive Pregnancy.
    Kitt J, Biasiolli L, Krasner S, Bateman PA, et al · · 2025 · PMID 40905148 · DOI 10.1161/hypertensionaha.125.24854
  7. Subclinical Postpartum Renal Structure After Hypertensive Pregnancy Disorders.
    Cutler HR, Kitt J, Sattwika PD, Finnigan LEM, et al · · 2025 · PMID 40886083 · DOI 10.1161/hypertensionaha.125.25130

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Other recruiting trials for Pre-Eclampsia

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