Prevent from home: young person and buddies’ cardiovascular health improvement feasibility study

ISRCTN	ISRCTN17524311
DOI	https://doi.org/10.1186/ISRCTN17524311
Integrated Research Application System (IRAS)	1008673
Central Portfolio Management System (CPMS)	61423
Protocol serial number	3641PHYLLIS
Sponsors	King's College London, King's College Hospital NHS Foundation Trust
Funder	National Institute for Health and Care Research

Submission date: 27/11/2024
Registration date: 22/01/2025
Last edited: 24/07/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Heart attacks and strokes cause the greatest number of preventable deaths in the UK. People from ethnic minority groups and those with socioeconomic deprivation are most severely affected. Women who develop high blood pressure or diabetes during pregnancy are up to ten times more likely to develop these problems in later life. New medications (sodium glucose transport protein-2 inhibitors, SGLT2i) can prevent heart attacks, strokes and kidney disease, they also reduce weight, blood pressure, and blood sugar but we do not know if they can prevent high blood pressure and diabetes development.
Women find it very difficult to take part in research in the postnatal period, particularly those from ethnic minorities. We have spoken to patients with lived experience of pregnancies complicated by high blood pressure and diabetes, in addition to members of the public, and co-designed a study to ensure the design best supports postnatal participation.
This is a feasibility study of a randomised controlled trial which will compare outcomes of women (and their study-buddies) who take SGLT2i with women who do not, and explore different ways to support postnatal women taking part in maternity research.

Who can participate?
Part A:
Person aged 18 years and over with current pregnancy, or within 6 weeks of pregnancy, complicated by hypertension

Part B:
Postpartum person (including people not identifying as female) aged 18 years and over with previous pregnancy complicated by HDP and/or GDM

Study buddy:
Aged 18 – 60 years with one or more pre-CVD risk factors:
1. Pre-hypertension
2. Parent or sibling with diabetes /body mass index (BMI) >30 kg/m2 /age >25 years if African Caribbean, Black African, or South Asian) AND HbA1C ≥42-47 mmol/mol (6-6.4%)
OR
3. Postpartum person with a previous pregnancy complicated by HDP and/or GDM

What does the study involve?
The study involves:
1. Using ‘postpartum health champions’ to support women taking part in the study
2. Home-testing and digital data entry
3. Using ‘study-buddies’ (a friend or family member with pre-diabetes or borderline high blood pressure) to support
women taking part in the study, in addition to increasing awareness and reassurance about research

What are the possible benefits and risks of participating?
Participants may be apprehensive about taking the study medication 'off label' but the approaching team member and study PIL will endeavour to provide participants with all the information they require to make an informed decision as to whether they take part. This will include ensuring participants understand that participation is voluntary and that they can stop taking part at any point. The prescribing healthcare professional will explain the medication's side effects, as per usual practice.
The study has been designed (with PPIE embedded) to facilitate recruitment and reduce participant burden. For example by reducing in-person contacts to two visits, and all other monitoring completed at home with digital data entry. Testing devices such as weighing scales and BP monitors can be kept after the study has finished. Study-buddy and postpartum champions will work to support study participation. A £10 gift voucher will thank participants for returning samples collected at home.
All clinical interventions included as part of this study are routinely administered and will not have additional risks above usual clinical care.

Where is the study run from?
King's College London (UK)

When is the study starting and how long is it expected to run for?
November 2024 to December 2028

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)

Who is the main contact?
Dr Kate Bramham, kate.bramham@kcl.ac.uk

Contact information

Dr Ann-Marie Murtagh
Scientific

King’s Health Partners Clinical Trials Office
Floor 16, Tower Wing
Guy’s Hospital
Great Maze Pond
London
SE19RT
United Kingdom

Phone	+44 (0)20 71885732
Email	QM.KHPCTO@kcl.ac.uk

Dr Jasmine Palmer
Scientific

The R&I Office
First Floor Coldharbour Works
245A Coldharbour Lane
London
SW98RR
United Kingdom

Phone	+44 (0)20 32991980
Email	kch-tr.research@nhs.net

Dr Kate Bramham
Principal investigator

Weston Education Centre
10 Cutcombe Road
London
SE5 9RJ
United Kingdom

Phone	+44 (0)7776 210747
Email	kate.bramham@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Open randomized controlled parallel-group trial
Secondary study design	Randomised controlled trial
Scientific title	Prevent from home: young person and buddies’ cardiovascular health improvement feasibility study (PHYLLIS)
Study acronym	PHYLLIS
Study objectives	Current study objectives as of 24/07/2026: To assess the feasibility of randomising postpartum individuals (with enhanced recruitment from under-served communities) with risk factors for cardiovascular disease to Sodium glucose transport protein-2 inhibitors (SGLT2i), Glucagon-like peptide 1 (GLP-1) and standard care. To optimise methodologies and collect data to inform future community-based point-of-care, digital and peer-supported / co-recruitment trials, with enhanced recruitment of participants from under-served communities. Primary Objective: Part A: To standardise baseline treatment to enalapril or other breastfeeding-compatible antihypertensive medication, prior to Part B Part B: To assess the feasibility of undertaking a randomised controlled trial comparing SGLT2i, GLP-1 and standard care in postpartum individuals with CVD risk factors, with peer support, optional co-recruitment (study-buddy) and remote monitoring. Secondary process objectives: 1. To determine adaptations to meet the needs of different under-served communities. 2. To explore the feasibility and acceptability of: 2.1. Recruiting peer-educator postpartum health champions 2.2. Co-recruitment of study-buddies 2.3. Novel community/home-based assessments of early endothelial dysfunction Secondary clinical objectives: To compare longitudinal changes in clinical parameters (including blood pressure, weight, cardiometabolic profile, anthropometric measures including waist, hip and upper arm circumference and assessments of endothelial dysfunction) for participants (and study-buddies) between study arms _____ Previous study objectives: To undertake a feasibility study for a randomised controlled trial comparing sodium glucose transport protein-2 inhibitors (SGLT2i) and standard care in postpartum women with risk factors for cardiovascular disease, with peer support, co-recruitment (study-buddy) and remote monitoring. Secondary process objectives: 1. To determine adaptations to meet the needs of different under-served communities 2. To explore the feasibility and acceptability of: 2.1. Recruiting peer-educator postpartum health champions 2.2. Co-recruitment of study-buddies 2.3. Novel community/home-based assessments of early endothelial dysfunction Secondary clinical objectives: To compare longitudinal changes in clinical parameters (including blood pressure, weight, cardiometabolic profile, anthropometric measures including waist, hip and upper arm circumference) for participants (and study-buddies) between study arms
Ethics approval(s)	Approved 20/01/2025, London - South East Research Ethics Committee (Health Research Authority, 2 Redman Place, London, E20 1JQ, United Kingdom; +44 (0)207 104 8222, +44 (0)207 104 8177, +44 (0)207 104 8263; londonsoutheast.rec@hra.nhs.uk), ref: 24/LO/0902
Health condition(s) or problem(s) studied	Hypertension in pregnancy, gestational diabetes
Intervention	Current interventions as of 24/07/2026: Part B: Intervention: (i) SGLT2i, oral dapagliflozin 10 mg once a day for 26 weeks; (ii) GLP-1, tirzepatide, weekly subcutaneous injections for 26 weeks. Starting dose will be 2.5mg for at least 4 weeks, with subsequent increases of 2.5 mg every 4 weeks based on symptom tolerance and weight loss response, up to a maximum dose of 15 mg. 52 weeks study duration with maximum duration on SGLT2i of 26 weeks; (ii) 52 weeks study duration with maximum duration on GLP-1 of 26 weeks _____ Previous interventions: 1:1 randomisation of postpartum individuals, who had pregnancies complicated by hypertensive disorders of pregnancy and/ or gestational diabetes, who have completed breastfeeding, to either 10 mg dapagliflozin once daily for 26 weeks, or standard care, with both arms offered additional support for participation in the form of remote monitoring, peer support or co-recruitment (“study buddy”). The follow-up period will be 52 weeks in total.
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Dapagliflozin/GLP-1, tirzepatide
Primary outcome measure(s)	The overall recruitment rate of postpartum participants with hypertension in pregnancy and/or gestational diabetes (number of participants per site per month, assessed at end of study). Determined from screening logs with eligibility criteria met and reasons for exclusion reported at the end of the study, defined as a database lock.
Key secondary outcome measure(s)	Current key secondary outcome(s) as of 24/07/2026: Process Endpoints: 1. Overall uptake and recruitment rate of study-buddies assessed at the end of the study. Determined from screening logs with eligibility criteria met and reasons for exclusion reported. 2. Longitudinal assessment of retention of postpartum participants and study-buddies across both arms (assessed at end of study) 3. Number of blood pressures, weights, pregnancy test results, urine-dip results (up to and including 26 weeks for each participant, total number assessed up to and including 52 weeks) from home results sent in by participants on the clinical portal (MyChart, or local patient electronic portal). 4. Number of returned blood and urine tests up to and including 26 weeks. 5. Evaluation of acceptability and experience of all study activities (For Part A: End of study survey and focus group at 16 weeks and for Part B: End of study survey with postpartum participants and study buddies at 52 weeks; focus group with postpartum participants, study buddies and health champions at 26 and 52 weeks) 6. Study resource use: Contacts with health champions, time for health champion training, expenditure on printing (£), time (hours) on recruitment and data extraction, home testing kit use (up to and including 26 weeks and 52 weeks) Clinical Endpoints: 7. Adherence to (i) daily SGLT2i (intervention arm 1) and weekly injections of GLP-1 (intervention arm 2) assessed either at 26 weeks by a member of the research team pill-counting, by reviewing 4 weekly photographs of drug blister packs, or patient’s diaries. Adherence will also be assessed at 16 weeks in Part A and at 26 weeks in Part B using the Medication Adherence Report Scale-5 (MARS-5). 8. Pregnancy rate during the study period (Part B) and pregnancy outcomes (pregnancy tests performed 4 weekly, overall pregnancy rates assessed at end of study) recorded in Macro database 9. Longitudinal changes in BP and weight at 4 weekly intervals, and 26 and 52 weeks sent in by participants on the clinical portal (MyChart or local patient electronic portal) and recorded in the Macro database 10. Longitudinal changes in creatinine, HbA1C, lipid profile and liver function tests (Thriva) and albumin creatinine ratio (ACR) (Synnovis) at 2, 14, and 38-weeks from home testing recorded in Macro database. 11. Longitudinal changes in anthropometric measures (waist, hip and upper arm circumference), creatinine, cystatin, HbA1C, cholesterol and ACR at baseline, 26 and 52 weeks from onsite testing (Synnovis) recorded in Macro database. 12. Longitudinal changes in retinal measurements (as measured by ophthalmic assessment), cardiac structure and function (as measured by echocardiography and electrocardiogram), pulse wave velocity and metabolomic profiles. _____ Previous key secondary outcome(s): Process Endpoints: 1. Overall uptake and recruitment rate of study-buddies assessed at the end of the study. Determined from screening logs with eligibility criteria met and reasons for exclusion reported. 2. Longitudinal assessment of retention of postpartum participants and study buddies across both arms (assessed at end of study) 3. Number of blood pressures, weights, pregnancy test results, urine-dip results (at 26 weeks for each participant, total number assessed at end of study) from home results sent in by participants on the clinical portal (MyChart, or local patient electronic portal). 4. Number of returned blood and urine tests at 26 weeks 5. Acceptability and experience of all study activities: end of study survey with postpartum participants and study buddies at 52 weeks; focus group with postpartum participants, study buddies and health champions at 26 and 52 weeks 6. Study resource use: contacts with health champions, time for health champion training, expenditure on printing (£), time (hours) on recruitment and data extraction, home testing kit use (at 26 weeks and 52 weeks) Clinical Endpoints: 7. Adherence to daily SGLT2i (intervention arm) assessed either at 26 weeks by a member of the research team pill-counting, or by reviewing 4 weekly photographs of drug blister packs 8. Pregnancy rate during the study period (Part B) and pregnancy outcomes (pregnancy tests performed 4 weekly, overall pregnancy rates assessed at the end of the study) recorded in the Macro database 9. Longitudinal changes in BP and weight at 4 weekly intervals, and 26 and 52 weeks sent in by participants on the clinical portal (MyChart or local patient electronic portal) and recorded in the Macro database 10. Longitudinal changes in creatinine, HbA1C, lipid profile and liver function tests (Thriva) and albumin creatinine ratio (ACR) (Synnovis) at 2, 14, and 38 weeks from home testing recorded in the Macro database 11. Longitudinal changes in anthropometric measures (waist, hip and upper arm circumference), creatinine, cystatin, HbA1C, cholesterol and ACR at baseline, 26 and 52 weeks from onsite testing (Synnovis) recorded in Macro database
Completion date	31/12/2028

Eligibility

Participant type(s)	Healthy volunteer, Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	120 Years
Sex	Female
Target sample size at registration	108
Key inclusion criteria	Current key inclusion criteria as of 24/07/2026: Part A: 1. Person with current pregnancy, or within six weeks of pregnancy, complicated by hypertension 2. Able to provide written informed consent 3. Age ≥ 18 years 4. Body mass index >23kg/m² Part B: Postpartum person (including people not identifying as female) with: 1. Previous pregnancy complicated by hypertension in pregnancy and/or gestational diabetes (defined by National Institute for Health and Care Excellence) ≤12-months 2. Able to provide written informed consent 3. Age ≥ 18 years 4. Completed breastfeeding 5. Body mass index ≥27kg/m² Study buddy: Study buddy (co-recruitment as selected by the postpartum person): 1. Age 18 years – 60 years 2. Body mass index ≥27kg/m² 3. Able to provide written informed consent 4. Person with ≥1 of the following pre-cardiovascular disease risk factor (NICE 2024): 4.1. Pre-hypertension (systolic blood pressure 120- 139 and/or diastolic blood pressure 80-89 mmHg) 4.2. Parent or sibling with diabetes or body mass index >30kg/m2 AND age > 25 years if African Caribbean, Black African, or South Asian or age > 40 years if any other ethnicity AND Haemoglobin A1c of 42-47 mmol/mol (6-6.4%) 4.3. Postpartum person with previous pregnancy complicated by hypertension in pregnancy and/or gestational diabetes >12-months _____ Previous key inclusion criteria: Part A: 1. Person with current pregnancy, or within 6 weeks of pregnancy, complicated by hypertension 2. Able to provide written informed consent 3. Age ≥ 18 years 4. Body mass index >17 kg/m² Part B: Postpartum person (including people not identifying as female): 1. Previous pregnancy complicated by HDP and/or GDM (defined by NICE) ≤12 months 2. Able to provide written informed consent 3. Age ≥18 years 4. Completed breastfeeding 5. Body mass index >17 kg/m2 Study buddy: 1. Able to provide written informed consent 2. Age 18 – 60 years with ≥1 pre-CVD risk factor: 2.1. Pre-hypertension (systolic BP 120-139 mmHg and/or diastolic BP 80-89 mmHg) 2.2. Parent or sibling with diabetes or body mass index >30 kg/m2 AND age>40 years if White or age>25 years if African Caribbean, Black African, or South Asian AND Haemoglobin A1c ≥42-47 mmol/mol (6-6.4%) OR 2.3. Postpartum person with a previous pregnancy complicated by HDP and/or GDM >12 months 3. Body mass index >17 kg/m2
Key exclusion criteria	Current key exclusion criteria as of 24/07/2026: Part A: Pregnant or postpartum person (including people not identifying as female) with: 1. Diabetes (Type-1 or 2) 2. Chronic Kidney Disease or Heart failure and recommended routine SGLT2i 3. Severe hepatic impairment 4. Allergy to dapagliflozin (SGLT2i), tirzepatide (GLP-1) or its excipients 5. Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption 6. Contraindication to postpartum enalapril, amlodipine, nifedipine, or labetalol - including allergy 7. Moving away from study site within 12 months 8. Planning pregnancy ≤6-months Part B: Postpartum person and study-buddies with: 1. Diabetes (Type-1 or 2), or history of diabetic ketoacidosis or hyperosmolar state or diabetic coma 2. Chronic Kidney Disease or Heart failure and recommended routine SGLT2i 3. Liver disease (AST or ALT > 2x upper limit of normal) 4. History of acute or chronic pancreatitis 5. Severe gastrointestinal disease 6. Oral medications with a narrow therapeutic window (e.g. warfarin, digoxin) 7. Any drug associated with hypoglycaemia (e.g. antimalarial agents, lithium) 8. Allergy to dapagliflozin (SGLT2i), tirzepatide (GLP-1), or its excipients 9. Pregnant, planning pregnancy within 6 months or breastfeeding (females of childbearing potential with a positive pregnancy test at screening) 10. Moving away from study site within 12 months 11. Severe hepatic impairment 12. Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption 13. Use of GLP-1 receptor agonists within the past 3 months 14. History of organ transplantation * A pregnancy test (urine) will be performed for all persons of childbearing potential at all onsite visits and monthly at home tests performed. Study drugs will not be dispensed without a negative pregnancy test. Women randomised to tirzepatide on oral contraception will be counselled on the potential for reduced efficacy and advised to use a barrier method or switch to non-oral contraception methods _____ Previous key exclusion criteria: Part A: Pregnant or postpartum person (including people not identifying as female) with: 1. Diabetes (Type 1 or 2) 2. Chronic kidney disease or heart failure and recommended routine SGLT2i 3. Liver disease (AST/ALT >2x upper limit of normal) 4. Allergy to dapagliflozin or its excipients 5. Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption 6. Moving away from the study site within 12 months 7. Severe hepatic impairment 8. Contraindication to postpartum enalapril, amlodipine, nifedipine, or labetalol - including allergy 9. Planning pregnancy ≤6 months Part B: Postpartum person (including people not identifying as female) and study-buddies with: 1. Diabetes (Type 1 or 2) 2. Chronic kidney disease or heart failure and recommended routine SGLT2i 3. Liver disease (AST/ALT > 2x upper limit of normal) 4. Allergy to dapagliflozin or its excipients 5. Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption 6. Pregnant, planning pregnancy within 6 months or breastfeeding (females of childbearing potential* with a positive pregnancy test at screening) 7. Moving away from the study site within 12 months 8. Severe hepatic impairment
Date of first enrolment	31/03/2025
Date of final enrolment	01/02/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

King's College Hospital NHS Foundation Trust

Denmark Hill
London
SE5 9RS
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version 5.0	25/02/2025	24/07/2026	No	No

Additional files

ISRCTN17524311 PHYLLIS Protocol v5.0 25Feb25.pdf: Protocol file

Editorial Notes

24/07/2026: The following changes were made to the study record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The study objectives were changed.
3. The interventions were changed.
4. The drug name was changed from Dapagliflozin to Dapagliflozin/GLP-1, tirzepatide.
5. The key secondary outcome(s) were changed.
6. The key inclusion criteria were changed.
7. The key exclusion criteria were changed.
25/02/2026: The following changes were made to the study record:
1. The date of final enrolment was changed from 01/02/2026 to 01/02/2027.
2. The completion date was changed from 31/12/2027 to 31/12/2028.
10/02/2026: Internal review.
18/03/2025: The recruitment start date was changed from 17/03/2025 to 31/03/2025.
18/01/2025: ISRCTN received notification of combined HRA/MHRA approval for this trial on 18/01/2025.
27/11/2024: Study's existence confirmed by the HRA.