List of study aims and objectives with respective timepoint (s) for the measurement of each objective
Objectives | Outcome measures | Timepoint(s) | |
Primary | To compare postpartum diastolic BP in the intervention arm vs the control arm. | 24-hour average diastolic BP measured by SPACELAB 90217 24 hours ABPM | Visit 4 (6–9 months post partum) |
Secondary | To compare the effect of the intervention on cardiovascular, cerebrovascular and vascular phenotypes | BP based
| 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
| For cardiac MRI at 6–12 months post partum | ||
Echo
| At baseline and at 6–12 months post partum for echo outcome measures | ||
Vascular
| PWV, Aortic BP and AI at baseline and at 6–12 months (aortic stiffness); aortic compliance (on MRI) at 6–12 months | ||
Cerebrovascular
| 6–12 months post partum for all Brain MRI measures. | ||
Retinal
| 6–12 months post partum for all retinal measures | ||
Tertiary | Exercise 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 women | Assessment 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 function | From baseline to 6–12 months post partum | |
T1 mapping of the kidneys to look at cortico-medullary differentiation | 6–12 months post partum | ||
To explore presence/absence of kidney injury and fibro-inflammatory status | EQ-5D-5L health questionnaire results | Baseline, week 1, week 6 and 6–12 months post partum | |
Quality of life assessment | Qualitative semistructured interviews in a subset of individuals as well as assessment of acceptability and feasibility within the intervention arm | 6–12 months post partum | |
Participant experience: assessment of individual experience following intervention | Readmission number in each arm | 0–12 months post partum | |
No of readmissions in intervention versus control arm | Number and frequency of side effects reported (intervention via the app and control during follow up calls | 0–12 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. | ||
Comparator | The 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.