Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 16 Years and Over
Gender Female
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05679206
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital Inselspital, Berne
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Emrush Rexhaj, MD
Principal Investigator Affiliation Insel Gruppe AG, Inselspital, Bern
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pre-Eclampsia; Complicating Pregnancy, Antiphospholipid Syndrome in Pregnancy, Pulmonary Hypertension
Additional Details

Preeclampsia (PE), a multisystem disease affecting 2-8% of all pregnancies is a major cause of mother and child mortality and morbidity worldwide. On the long term, women who suffered from PE during pregnancy are prone to develop various cardiovascular diseases including arterial hypertension, heart failure, aortic stenosis, mitral regurgitation and atrial fibrillation. In an effort to prevent or early detect any potential cardiovascular complications in this population, the investigators implemented in Inselspital, 6 years ago, a join consultation between cardiologist and obstetrician. Since 2016, a roughly 100 women/year have been followed at this consultation. As part of this follow-up, in addition to a clinical examination, echocardiography, blood sampling and 24h ambulatory blood pressure monitoring were performed. To the best of the investigators knowledge, this represent the first cohort of this kind in Switzerland. Therefore, it offers a unique opportunity to study the effect of PE on the long term cardiovascular phenotype. Although the majority of PE are of unknown origin a fraction is due to an autoimmune disease, the Antiphospholipid Syndrome (APS). APS is known to triple the risk of developing PE and is found in up to 20% in women with the most severe forms of PE. There are two distinguished entities of APS, one associated with vascular complications (vascular APS) and one associated with adverse pregnancy outcomes (obstetric APS (oAPS)). In the former form, the prevalence of pulmonary hypertension has been reported to be between 2% and 17% (incidence in the general population ~ 1/100'000) but remain unknown in oAPS. This is of prime importance as pulmonary arterial hypertension is a rare disease with elevated mortality and limited treatment availability. Furthermore, for unknown raison, women have up to seven times the risk of men to develop PH. Here, the investigators hypothesize that oAPS could be an unrecognized risk factor for the development of PH in women. In patients who suffered from PE, epidemiological studies shown that the risk for developing arterial hypertension, stroke or heart failure is 2-4 fold higher. But structured follow-up to better target this population is missing. Our established interdisciplinary consultation offer a unique possibility to better understand the link between PE and cardiovascular outcomes later in life. Therefore, the investigators further aimed in this study, first to assess the prevalence of the above mentioned cardiovascular outcomes, and second, to establish prediction models, for example for the development of arterial hypertension in patient that suffered from PE. The primary objective of this study is to compare the postpartum pulmonary arterial pressure measured non-invasively by echocardiography in women after PE with or without oAPS by collecting routine data for the analysis.The secondary objective is to compare the right and left cardiac function using echocardiography images and the systemic blood pressure between both groups by collecting routine data for the analysis. Further, the investigators aimed to assess the prevalence of arterial hypertension in this population, 3 years postpartum and establish a prediction model of the development of arterial hypertension by collecting routine data for the analysis. The investigators are planning a single center retrospective and prospective study where routine data is collected to evaluate the objectives described above. In particular, demographic, biophysical as well as echocardiographic parameters of all the patients whose pregnancies were complicated by preeclampsia, and were or will be referred after delivery to our outpatient clinic will be collected and analyzed. All consenting patients (see chapter 9) followed between 2016 and 2025 will be enrolled. All data will be collected during a period ranging from 2016 to 2028 encompassing the first patient enrolment in 2016 and the end of the 3 years routine follow-up of the last patient enrolled in 2025.

Arms & Interventions

Arms

: 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.

: 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.

Interventions

Diagnostic Test: - Echocardiography images

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

Diagnostic Test: - 24-hour ambulatory blood pressure monitoring

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

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International Sites

Inselspital, Bern, Switzerland

Status

Recruiting

Address

Inselspital

Bern, , 3010

Site Contact

Emrush Rexhaj, MD

emrush.rexhaj@insel.ch

+41316322111

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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