Blood Pressure After PREeclampsia/HELLP by SELF Monitoring Study

Hypertension Clinical Trial

— BP-PRESELF  

Official title:

Blood Pressure After PREeclampsia/HELLP by SELF Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228082
• Other study ID #: NL59836.091.16
• Status: Completed
• Phase: N/A
• Start date: July 13, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: October 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE:

Women with a previous history of preeclampsia (PE)/HELLP have a twofold higher risk of cardiovascular disease (CVD) and a fourfold increased risk to develop hypertension at a relative young age. In the latest 2016 ESC guidelines 'CVD prevention', previous PE has been acknowledged as a serious CVD risk factor in women. In clinical practice, however, these women are still underappreciated for their CVD risk. It has not been established yet how adequate lifelong prevention in these potentially high risk women can optimally be achieved from their childbearing years onwards.

OBJECTIVE:

To evaluate feasibility, usability, acceptance and potential obstacles of blood pressure (BP) home monitoring in high-risk women, aged 40-60 years, after a previous PE in pregnancy. In addition to evaluate the effectiveness of BP home monitoring on the occurrence of hypertension, the efficacy of BP treatment, quality of life (QOL), health-related symptoms, work ability and life-style behaviour.

STUDY DESIGN:

Randomized, open label feasibility study to compare eHealth guided self management of BP monitoring and lifestyle advice with 'usual care'.

STUDY POPULATION:

Approximately 200 women, aged ≥ 40 and ≤ 60 years, with a previous PE in pregnancy will be invited to participate (both early and late PE). Patients will be recruited from the departments of obstetrics/gynaecology in 6 centres in the Euregio Rhein-Waal and from the department of cardiology Radboudumc.

INTERVENTION:

eHealth guided measurements of BP at regular intervals and recurrent lifestyle advice (intervention-group) will be compared with "usual care".

PRIMARY OUTCOME:

Feasibility, usability, acceptance and potential obstacles of BP home monitoring in high-risk women after a previous PE in pregnancy at 1 year of follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• previous preeclampsia/HELLP syndrome, defined as diastolic BP=90 mmHg with proteinuria = 0.3gram/24 h, during one or more pregnancies, more than 1 year ago.

• 'early' or 'late' PE/HELLP

• age =40 and = 60 years

Exclusion Criteria:

• pregnant women or women wishing for future pregnancie(s)

• inability to perform self BP measurements

• not having a smartphone (Apple or Android)

• already having regular hypertension control by GP or medical specialist

• previous cardiovascular events, such as myocardial infarction , stroke, heart failure and symptomatic ischemic heart disease

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor
• Hypertension
• Pre-Eclampsia
• Preeclampsia

Intervention

Device:
• Home Blood Pressure Monitoring (HBPM)
Home blood pressure monitoring using the Withings Wireless BP monitor. Patients will be asked to measure their blood pressure twice daily for 7 consecutive days. This will be repeated for every month for 1 year.

Locations

Country	Name	City	State
Germany	Katholisches Karl-Leisner-Klinikum GmbH	Kleve
Germany	Krankenhaus Bethanien	Moers
Germany	St. Josef Krankenhaus GmbH	Moers
Netherlands	Rijnstate Ziekenhuis	Arnhem
Netherlands	Canisius-Wilhelmina Ziekenhuis	Nijmegen
Netherlands	Radboudumc	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	INTERREG V-A

Countries where clinical trial is conducted

Germany,  Netherlands, 

References & Publications (17)

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Brown MC, Best KE, Pearce MS, Waugh J, Robson SC, Bell R. Cardiovascular disease risk in women with pre-eclampsia: systematic review and meta-analysis. Eur J Epidemiol. 2013 Jan;28(1):1-19. doi: 10.1007/s10654-013-9762-6. Epub 2013 Feb 9. Review. — View Citation

Bushnell C, McCullough LD, Awad IA, Chireau MV, Fedder WN, Furie KL, Howard VJ, Lichtman JH, Lisabeth LD, Piña IL, Reeves MJ, Rexrode KM, Saposnik G, Singh V, Towfighi A, Vaccarino V, Walters MR; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council for High Blood Pressure Research. Guidelines for the prevention of stroke in women: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 May;45(5):1545-88. doi: 10.1161/01.str.0000442009.06663.48. Epub 2014 Feb 6. Review. Erratum in: Stroke. 2014 Oct;45(10);e214. Stroke.2014 May;45(5):e95. — View Citation

Drost JT, Arpaci G, Ottervanger JP, de Boer MJ, van Eyck J, van der Schouw YT, Maas AH. Cardiovascular risk factors in women 10 years post early preeclampsia: the Preeclampsia Risk EValuation in FEMales study (PREVFEM). Eur J Prev Cardiol. 2012 Oct;19(5):1138-44. doi: 10.1177/1741826711421079. Epub 2011 Aug 22. — View Citation

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Heida KY, Bots ML, de Groot CJ, van Dunné FM, Hammoud NM, Hoek A, Laven JS, Maas AH, Roeters van Lennep JE, Velthuis BK, Franx A. Cardiovascular risk management after reproductive and pregnancy-related disorders: A Dutch multidisciplinary evidence-based guideline. Eur J Prev Cardiol. 2016 Nov;23(17):1863-1879. Epub 2016 Jul 18. Review. — View Citation

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Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Groen SE, Kadrmas HM, Kerby TJ, Klotzle KJ, Maciosek MV, Michels RD, O'Connor PJ, Pritchard RA, Sekenski JL, Sperl-Hillen JM, Trower NK. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013 Jul 3;310(1):46-56. doi: 10.1001/jama.2013.6549. — View Citation

McDonald SD, Malinowski A, Zhou Q, Yusuf S, Devereaux PJ. Cardiovascular sequelae of preeclampsia/eclampsia: a systematic review and meta-analyses. Am Heart J. 2008 Nov;156(5):918-30. doi: 10.1016/j.ahj.2008.06.042. Epub 2008 Oct 2. Review. — View Citation

McManus RJ, Mant J, Bray EP, Holder R, Jones MI, Greenfield S, Kaambwa B, Banting M, Bryan S, Little P, Williams B, Hobbs FD. Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trial. Lancet. 2010 Jul 17;376(9736):163-72. doi: 10.1016/S0140-6736(10)60964-6. Epub 2010 Jul 8. — View Citation

McManus RJ, Mant J, Haque MS, Bray EP, Bryan S, Greenfield SM, Jones MI, Jowett S, Little P, Penaloza C, Schwartz C, Shackleford H, Shovelton C, Varghese J, Williams B, Hobbs FD, Gooding T, Morrey I, Fisher C, Buckley D. Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial. JAMA. 2014 Aug 27;312(8):799-808. doi: 10.1001/jama.2014.10057. Erratum in: JAMA. 2014 Nov 26;312(20):2169. Gooding, Trevor [Added]; Morrey, Ian [Added]; Fisher, Crispin [Added]; Buckley, David [Added]. — View Citation

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Verberk WJ, Kroon AA, Lenders JW, Kessels AG, van Montfrans GA, Smit AJ, van der Kuy PH, Nelemans PJ, Rennenberg RJ, Grobbee DE, Beltman FW, Joore MA, Brunenberg DE, Dirksen C, Thien T, de Leeuw PW; Home Versus Office Measurement, Reduction of Unnecessary Treatment Study Investigators. Self-measurement of blood pressure at home reduces the need for antihypertensive drugs: a randomized, controlled trial. Hypertension. 2007 Dec;50(6):1019-25. Epub 2007 Oct 15. — View Citation

Writing Group Members, Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jiménez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. Erratum in: Circulation. 2016 Apr 12;133(15):e599. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life	QOL measures related to blood pressure by repeated validated questionnaires	1 year
Other	Occupational activity	Questionnaires on ability to work and work-related obstacles	1 year
Other	BP patterns	Patterns of BP levels and incidence of hypertension during follow-up	1 year
Other	Cardiac symptoms	Cardiac symptoms and blood-pressure related symptoms	1 year
Other	Costs	Cost-effectiveness of BP self-management versus regular office-based visits	1 year
Primary	Feasibility of HBPM after a previous preeclampsia to evaluate the prevalence of hypertension.	To evaluate feasibility of blood pressure home monitoring to diagnose hypertension at 1 year follow-up, in high-risk women with a previous preeclampsia. Feasibility will be measured using questionnaires (Likert scales).	1 year
Secondary	Blood pressure values	Mean BP values (mmHg) in both study groups at 1 year of follow-up	1 year
Secondary	Prevalence of hypertension	Prevalence of hypertension in both groups at 1 year of follow-up	1 year
Secondary	Effect HBPM	Effect of regular self measurements on blood pressure levels at home at 1 year follow-up	1 year