Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure

NCT05679206 | Recruiting

• 1 other identifier: 2022-01957
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this observational study is to learn about postpartum pulmonary artery pressure in women who suffered from Preeclampsia and Antiphospholipid Syndrome. The main question it aims to answer is whether the conjunction of preeclampsia with obstetric antiphospholipid syndrome significantly foster the development of long-lasting pulmonary hypertension. Only participants who suffered from preeclampsia during pregnancy will be followed for a period up to 3 years postpartum. Researchers will compare women with or without obstetric antiphospholipid syndrome.

Conditions

Pre-Eclampsia; Complicating Pregnancy; Antiphospholipid Syndrome in Pregnancy; Pulmonary Hypertension

Keywords

Pre-Eclampsia; Antiphospholipid Syndrome in Pregnancy; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Changes in systolic pulmonary artery pressure

  Right ventricle to right atrium (RV/RA) gradient will be mesured using echocardiography

  three months and three years after delivery

Secondary Outcomes (1)

• Changes in systemic arterial blood pressure

  three months and three years after delivery

Study Arms (2)

Preeclampsia and obstetric Antiphospholipid Syndrome

Women in this group wil be followed during 3 years. Echocardiography images, 24-hour ambulatory blood pressure monitoring will be collected.

Diagnostic Test: Echocardiography images; Diagnostic Test: 24-hour ambulatory blood pressure monitoring

Preeclampsia without obstetric Antiphospholipid Syndrome

Women in this group wil be followed during 3 years. Echocardiography images, 24-hour ambulatory blood pressure monitoring will be collected.

Diagnostic Test: Echocardiography images; Diagnostic Test: 24-hour ambulatory blood pressure monitoring

Interventions

Echocardiography images DIAGNOSTIC_TEST

Transthoracic echocardiographic (Vivid E95) performed in all included patients between three months and three years after delivery. * Left ventricular ejection fraction, * Left ventricular mass index, * Septal and lateral mitral annular E-wave velocity assessed by tissue Doppler, * Tricuspid annular plane systolic excursion, * Left atrial volume index, * Right ventricle to right atrium (RV/RA) gradient

Preeclampsia and obstetric Antiphospholipid Syndrome; Preeclampsia without obstetric Antiphospholipid Syndrome

24-hour ambulatory blood pressure monitoring DIAGNOSTIC_TEST

Twenty-four-hour ABPM performed between three months and three years after delivery using validated recorders (Spacelabs model 90217, USA)

Preeclampsia and obstetric Antiphospholipid Syndrome; Preeclampsia without obstetric Antiphospholipid Syndrome

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will retrospectively and prospectively study a cohort of PE patient followed at our interdisciplinary postpartum consultation. Informed consent was/will be obtained by means of a general consent. Only for the analysis relevant clinical data (i.e. Echocardiography, ABPM and blood sampling results) will be extracted from the patient files and encoded (according Swissethics guideline) for further analysis.

You may qualify if:

• Age: \> 16 years.
• Consent or waiver of consent according Chapter 9
• Preeclampsia
• Defined as:
• New onset hypertension (blood pressure \>140/90mmHg on multiple occasions after 20 weeks of gestation)
• In combination with new onset of 1 or more of the following:
• Proteinuria (urine protein \>300mg /24h or 2+ or higher in dipstick on multiple occasions)
• Platelet count \<100,000/microL,
• Serum creatinine \>97.2 micromol/L,
• Liver transaminases at least twice the upper limit of the normal concentrations,
• Pulmonary edema,
• New-onset and persistent headache,
• Visual symptoms. -Postnatal follow up at the obstetrical and cardiology clinic, Inselspital Bern, Switzerland.

You may not qualify if:

• Age: \< 16 years
• Incomplete or ambiguous data: if data confirming the eligibility criteria or data to analyze the primary endpoint is not fully available or despite efforts assessed as significantly ambiguous, the data set will be excluded from analyses, since no analysis is possible

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital

Bern, 3010, Switzerland

RECRUITING

Related Publications (7)

• Benschop L, Duvekot JJ, Roeters van Lennep JE. Future risk of cardiovascular disease risk factors and events in women after a hypertensive disorder of pregnancy. Heart. 2019 Aug;105(16):1273-1278. doi: 10.1136/heartjnl-2018-313453. Epub 2019 Jun 7.

  PMID: 31175138 BACKGROUND

• Brown MA, Magee LA, Kenny LC, Karumanchi SA, McCarthy FP, Saito S, Hall DR, Warren CE, Adoyi G, Ishaku S; International Society for the Study of Hypertension in Pregnancy (ISSHP). The hypertensive disorders of pregnancy: ISSHP classification, diagnosis & management recommendations for international practice. Pregnancy Hypertens. 2018 Jul;13:291-310. doi: 10.1016/j.preghy.2018.05.004. Epub 2018 May 24. No abstract available.

  PMID: 29803330 BACKGROUND

• Heilmann L, Schorsch M, Hahn T, Fareed J. Antiphospholipid syndrome and pre-eclampsia. Semin Thromb Hemost. 2011 Mar;37(2):141-5. doi: 10.1055/s-0030-1270341. Epub 2011 Mar 2.

  PMID: 21370215 BACKGROUND

• Honigberg MC, Zekavat SM, Aragam K, Klarin D, Bhatt DL, Scott NS, Peloso GM, Natarajan P. Long-Term Cardiovascular Risk in Women With Hypertension During Pregnancy. J Am Coll Cardiol. 2019 Dec 3;74(22):2743-2754. doi: 10.1016/j.jacc.2019.09.052. Epub 2019 Nov 11.

  PMID: 31727424 BACKGROUND

• Leon LJ, McCarthy FP, Direk K, Gonzalez-Izquierdo A, Prieto-Merino D, Casas JP, Chappell L. Preeclampsia and Cardiovascular Disease in a Large UK Pregnancy Cohort of Linked Electronic Health Records: A CALIBER Study. Circulation. 2019 Sep 24;140(13):1050-1060. doi: 10.1161/CIRCULATIONAHA.118.038080. Epub 2019 Sep 23.

  PMID: 31545680 BACKGROUND

• Olie V, Moutengou E, Grave C, Deneux-Tharaux C, Regnault N, Kretz S, Gabet A, Mounier-Vehier C, Tsatsaris V, Plu-Bureau G, Blacher J. Prevalence of hypertensive disorders during pregnancy in France (2010-2018): The Nationwide CONCEPTION Study. J Clin Hypertens (Greenwich). 2021 Jul;23(7):1344-1353. doi: 10.1111/jch.14254. Epub 2021 May 27.

  PMID: 34042277 BACKGROUND

• Rana S, Lemoine E, Granger JP, Karumanchi SA. Preeclampsia: Pathophysiology, Challenges, and Perspectives. Circ Res. 2019 Mar 29;124(7):1094-1112. doi: 10.1161/CIRCRESAHA.118.313276.

  PMID: 30920918 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Pregnancy Complications; Hypertension, Pulmonary

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Emrush Rexhaj, MD

  Insel Gruppe AG, Inselspital, Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emrush Rexhaj, MD

CONTACT

+41 31 632 21 11; emrush.rexhaj@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hypertension, Principal Investigator

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 10, 2023
• Study Start: December 20, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)