CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 200 target
Drug / intervention
OMRON Evolv® blood pressure monitor (Blue-tooth® enabled) & Proprietary Smartphone POP-HT app®device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04273854
NCT04273854N/AActiveUpdate OverdueUpdated 56mo ago · Completion was 51mo ago
Enrollment Stalled

Physician Optimised Post-partum Hypertension Treatment Trial

University of Oxford·interventional·Posted Feb 18, 2020·Updated Oct 22, 2021

In Brief

A clinical study evaluating OMRON Evolv® blood pressure monitor (Blue-tooth® enabled) & Proprietary Smartphone POP-HT app® for Pre-Eclampsia and Gestational Hypertension. Active but no longer recruiting, targeting 200 participants across 2 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/AActive
202020212022202320242025202620272028202920302031
First PostedFeb 18, 2020
Enrollment StartFeb 21, 2020
Primary CompletionApr 1, 2022
Study CompletionDec 1, 2030
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.4 years ago

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.