Table 1

List of study aims and objectives with respective timepoint (s) for the measurement of each objective

ObjectivesOutcome measuresTimepoint(s)
PrimaryTo compare postpartum diastolic BP in the intervention arm vs the control arm.24-hour average diastolic BP measured by SPACELAB 90217 24 hours ABPMVisit 4 (6–9 months post partum)
SecondaryTo compare the effect of the intervention on cardiovascular, cerebrovascular and vascular phenotypesBP based
  • 24-hour average systolic blood pressure assessed by SPACELAB 90217 24-hour ABPM

  • Mean diurnal diastolic blood pressure assessed by SPACELAB 90217 ABPM

  • Mean diurnal systolic blood pressure assessed by SPACELAB 90217 ABPM

  • Mean nocturnal diastolic blood pressure assessed by SPACELAB 90217 24-hour ABPM

  • Mean nocturnal systolic blood pressure assessed by SPACELAB 90217 24-hour ABPM

  • Mean bedside diastolic blood pressure measured during study visit (mean of 2+3)

  • Mean bedside systolic blood pressure measured during study visit (mean of 2+3)

6-9 months for the 24-hour ABPM measures
Baseline, week 1, week 6 and 6–9 months for the bedside BP measures
Cardiac MRI
  • Left ventricular (LV) mass indexed to end-diastolic volume and body surface area (BSA)

  • LV EDV indexed to BSA

  • LV wall thickness

  • LA volume indexed to BSA

  • Right ventricular (RV) mass indexed to end-diastolic volume and body surface area

  • RV EDV indexed to BSA

  • RA volume indexed to BSA

  • LV ejection fraction (EF) and RVEF

  • LV and RV stroke volumes indexed to BSA

  • Myocardial fibrosis

  • ECV (extracellular volume)

For cardiac MRI at 6–12 months post partum
Echo
  • LV Diastolic function:E/E’ average, E/A ratio, E deceleration time

  • Global longitudinal strain (GLS)

  • LV systolic function (EF by Biplane Simpson’s)

  • LA volume by Biplanar assessment

At baseline and at 6–12 months post partum for echo outcome measures
Vascular
  • Pulse wave velocity

  • Augmentation index and Aortic BP

  • Aortic distensibility (MRI)

PWV, Aortic BP and AI at baseline and at 6–12 months (aortic stiffness); aortic compliance (on MRI) at 6–12 months
Cerebrovascular
  • Total white matter hyperintensity volume

  • Cerebral blood flow

  • Mean vessel thickness of the middle and posterior cerebral arteries and internal carotid artery

6–12 months post partum for all Brain MRI measures.
Retinal
  • The corrected central retinal arteriolar equivalent

  • The corrected central retinal venular equivalent

  • Corrected central retinal arteriolar equivalent/corrected central retinal venular equivalent ratio.

6–12 months post partum for all retinal measures
TertiaryExercise echo
Exercise ejection fraction (echo) and exercise LA volume at 50% of peak workload during a bicycle cardiopulmonary exercise test (CPET)
6–12 months post partum
CPET
VO2 at VT1
6–12 month post partum
To explore in vitro vascular function in a substudy of 20 womenAssessment of endothelial cell function and circulating biomarker levels associated with vascular angiogenesis and inflammation in normotensive and hypertensive women to determine if BP improvement can affect vascular functionFrom baseline to 6–12 months post partum
T1 mapping of the kidneys to look at cortico-medullary differentiation6–12 months post partum
To explore presence/absence of kidney injury and fibro-inflammatory statusEQ-5D-5L health questionnaire resultsBaseline, week 1, week 6 and 6–12 months post partum
Quality of life assessmentQualitative semistructured interviews in a subset of individuals as well as assessment of acceptability and feasibility within the intervention arm6–12 months post partum
Participant experience: assessment of individual experience following interventionReadmission number in each arm0–12 months post partum
No of readmissions in intervention versus control armNumber and frequency of side effects reported (intervention via the app and control during follow up calls0–12 months post partum
Side effect impact
Intervention(s)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 review the uploaded readings and respond to telemonitored abnormal readings in a timely fashion.
ComparatorThe control arm will be managed as per usual NHS-led care with assessment by their own healthcare professionals and adjustment of medications as required. 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 with all other secondary outcome measures.
  • ABPM, Ambulatory Blood Pressure Monitoring ; AI, Augmentation Index; BP, blood pressure; EDV, End Diastolic Volume; EQ-5D-5L, The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression to assess quality of life; NHS, National Health Service; RA, Right atrial; RWT, Relative Wall thickness.