Physician Optimised Post-partum Hypertension Treatment Trial

NCT04273854 | Active Not Recruiting DMC

• 2 other identifiers: 273353FS/19/7/34148
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pre-Eclampsia; Gestational Hypertension

Outcome Measures

Primary Outcomes (1)

• Diastolic Blood pressure (BP)

  24 hour average diastolic BP measured by 24 hour ambulatory BP monitoring (ABPM)

  6 months post-partum

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention will consist of physician-optimised self-management of post-partum BP. Women will follow a 'smartphone' app based algorithm for medication-titration, which will provide individualised dose titration advice.

Device: OMRON Evolv® blood pressure monitor (Blue-tooth® enabled) & Proprietary Smartphone POP-HT app®

Control

NO INTERVENTION

The control arm will be managed as per usual NHS led care with assessment by their own health care professionals and adjustment of their medications as is needed. The BP of this group will be monitored and recorded at the same time-points and in the same manner as the intervention arm as will all other secondary outcome measures.

Interventions

OMRON Evolv® blood pressure monitor (Blue-tooth® enabled) & Proprietary Smartphone POP-HT app® DEVICE

The intervention will consist of physician-optimised self-management of post-partum BP. Women will follow a 'smartphone' app based algorithm for medication-titration, which will provide individualised dose titration advice. This is overseen and any change is approved by physicians who can review the uploaded readings and respond to tele-monitored abnormal readings in a timely fashion.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Must be female anatomy and genetically and have conceived and given birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the trial.
• Female, aged 18 years or above.
• Clinician confirmed diagnosis of either gestational hypertension or pre-eclampsia defined by NICE NG 133
• Requiring anti-hypertensive medication at the point of discharge from secondary care.
• Participant has clinically acceptable laboratory results and clinical course post-partum with no other adverse complicating factor requiring prolonged admission post-partum that would make participation unfeasible as judged by the CI. Examples would include stroke sequalae, ongoing DIC, the baby/babies requiring prolonged NICU/SCBU admission of \>1 week.
• In the Investigator's opinion, is able and willing to comply with all trial requirements including ownership of a 'Smart-phone/Tablet' and willing to use the smart-phone app if randomised to that arm.
• Sufficient competence in English Language to follow the app instructions and partake in the study, as judged by the CI

You may not qualify if:

• Significant renal or hepatic impairment that would affect safe medication titration and adjustment as part of the trial, as deemed by the Investigator.
• Scheduled elective surgery (excluding caesarean sections) or other procedures requiring general anaesthesia during the trial.
• Participant with life expectancy of less than 6 months.
• Any other significant disease or disorder, which, in the opinion of the Investigator, may either, put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
• An absolute contra-indication to MRI (as per MRI safety questionnaire)
• Women with pre-existing hypertension will be excluded, as this is a separate pathology that would affect the efficacy of the study intervention and affect the primary and secondary outcomes of the study.
• Breast feeding,
• eGFR \<30ml/minute.

Sponsors & Collaborators

• University of Oxford: lead
• British Heart Foundation: collaborator

Study Sites (2)

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordhsire, OX3 9DU, United Kingdom

Location

Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related Publications (6)

• Lapidaire W, Kitt J, Krasner S, Bateman PA, Cutler HR, Barr L, Frost A, Tucker K, Suriano K, Kenworthy Y, Milner G, Lacharie M, Mills R, Roman C, Mackillop L, Aye C, Cairns A, Thilaganathan B, Chappell LC, Lewandowski AJ, McManus RJ, Leeson P. Brain Volumes After Hypertensive Pregnancy and Postpartum Blood Pressure Management: A POP-HT Randomized Clinical Trial Imaging Substudy. JAMA Neurol. 2026 Jan 5:e255145. doi: 10.1001/jamaneurol.2025.5145. Online ahead of print.

  PMID: 41490362 DERIVED

• Kitt J, Biasiolli L, Krasner S, Bateman PA, Cutler HR, Barr LC, Frost A, Tucker KL, Suriano K, Kenworthy Y, Lapidaire W, Lacharie M, Mills R, Roman C, Mackillop L, Aye CYL, Cairns AE, Thilaganathan B, Chappell LC, Lewandowski AJ, McManus RJ, Leeson P. Impact of Blood Pressure Self-Management on Vascular Remodeling After Hypertensive Pregnancy. Hypertension. 2025 Nov;82(11):1938-1947. doi: 10.1161/HYPERTENSIONAHA.125.24854. Epub 2025 Sep 4.

  PMID: 40905148 DERIVED

• Cutler HR, Kitt J, Sattwika PD, Finnigan LEM, Estevez-Fernandez A, Kenworthy Y, Suriano K, Frost A, Krasner S, Johnson C, McCourt A, Mills R, Tucker K, Cairns A, Roman C, Aye C, Mackillop L, Thilaganathan B, Chappell LC, Raman B, Lewandowski AJ, Lapidaire W, Leeson P. Subclinical Postpartum Renal Structure After Hypertensive Pregnancy Disorders. Hypertension. 2025 Nov;82(11):1948-1958. doi: 10.1161/HYPERTENSIONAHA.125.25130. Epub 2025 Aug 31.

  PMID: 40886083 DERIVED

• Kitt J, Fox R, Frost A, Shanyinde M, Tucker K, Bateman PA, Suriano K, Kenworthy Y, McCourt A, Woodward W, Lapidaire W, Lacharie M, Santos M, Roman C, Mackillop L, Delles C, Thilaganathan B, Chappell LC, Lewandowski AJ, McManus RJ, Leeson P. Long-Term Blood Pressure Control After Hypertensive Pregnancy Following Physician-Optimized Self-Management: The POP-HT Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1991-1999. doi: 10.1001/jama.2023.21523.

  PMID: 37950919 DERIVED

• Kitt J, Krasner S, Barr L, Frost A, Tucker K, Bateman PA, Suriano K, Kenworthy Y, Lapidaire W, Lacharie M, Mills R, Roman C, Mackillop L, Cairns A, Aye C, Ferreira V, Piechnik S, Lukaschuk E, Thilaganathan B, Chappell LC, Lewandowski AJ, McManus RJ, Leeson P. Cardiac Remodeling After Hypertensive Pregnancy Following Physician-Optimized Blood Pressure Self-Management: The POP-HT Randomized Clinical Trial Imaging Substudy. Circulation. 2024 Feb 13;149(7):529-541. doi: 10.1161/CIRCULATIONAHA.123.067597. Epub 2023 Nov 11.

  PMID: 37950907 DERIVED

• Kitt J, Frost A, Mollison J, Tucker KL, Suriano K, Kenworthy Y, McCourt A, Woodward W, Tan C, Lapidaire W, Mills R, Lacharie M, Tunnicliffe EM, Raman B, Santos M, Roman C, Hanssen H, Mackillop L, Cairns A, Thilaganathan B, Chappell L, Aye C, Lewandowski AJ, McManus RJ, Leeson P. Postpartum blood pressure self-management following hypertensive pregnancy: protocol of the Physician Optimised Post-partum Hypertension Treatment (POP-HT) trial. BMJ Open. 2022 Feb 23;12(2):e051180. doi: 10.1136/bmjopen-2021-051180.

  PMID: 35197335 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All downstream data analysis will be done by investigators blinded to the allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 18, 2020
• Study Start: February 21, 2020
• Primary Completion: April 1, 2022
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)