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Physician Optimised Post-partum Hypertension Treatment Trial

NCT04273854 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-10-22

No results posted yet for this study

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

Interventions

DEVICE

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

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.

Sponsors & Collaborators

  • British Heart Foundation

    collaborator OTHER

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-21
Primary Completion
2022-04-01
Completion
2030-12-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04273854 on ClinicalTrials.gov