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ACTIVE NOT RECRUITING

NCT04273854

Physician Optimised Post-partum Hypertension Treatment Trial

Sponsor: University of Oxford

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2020-02-21

Completion Date

2030-12-01

Last Updated

2021-10-22

Healthy Volunteers

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.

Inclusion Criteria: * 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 Exclusion Criteria: * 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. Additional exclusion criteria specific to the Gadolinium sub-study are: * Breast feeding, * eGFR \<30ml/minute.

Locations (2)

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordhsire, United Kingdom

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

Oxford, Oxfordshire, United Kingdom