Biomarkers of CVD Dysfunction in Hypertensive Disorders of Pregnancy

NCT ID: NCT05806372

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2025-03-15

Brief Summary

Profound and concomitant cardiovascular hemodynamic changes, necessary to support fetoplacental development and its increasing supply demands, occur during a physiological pregnancy characterized by an increase in cardiac output, heart rate and plasma volume, and fall in vascular resistance and blood pressure. The result of these changes is a volume overload that will lead to a compensatory transient left ventricular eccentric hypertrophy. This, together with the pro-inflammatory state typical of pregnancy, represents the pregnancy as a stress-test for the maternal cardiovascular system. Pregnancies complicated by hypertensive disorders of pregnancy (HDP), particularly those with early onset and/or complicated by intrauterine fetal growth restriction (FGR), are characterized by a cardiovascular maladaptation. Women who experienced HDP in pregnancy, especially pre-eclampsia (PE), more often develop later in life ischemic heart disease, hypertension and stroke, obesity, dyslipidemia, and end-stage renal disease.

Regardless its clinical impact, very little knowledge is available on the mechanisms by which PE could lead to cardiovascular disease (CVD), and, especially, to heart failure after pregnancy. Preliminary results suggest a cross-talk between pregnancy-induced biomarkers and cardio-vascular system. Particularly, cultures of neonatal rat cardiomyocytes and fibroblasts were used to investigate the role of the serum of women with HDP in regulating their proliferation. 5-ethynyl-2'-deoxyuridine (EdU) was administered to label DNA synthesis in proliferating cells. After 3 days of in vitro culture, EdU incorporation was analyzed upon immunofluorescence staining using specific antibodies by high content microscopy. A possible protective effect exerted by the selected sera against apoptosis was evaluated, as well, by Caspase activation. Moreover, the effect of cardiomyocytes and fibroblasts proliferation and apoptosis on maternal hemodynamic parameters was evaluated using median regression models. These data show that the serum of women with HDP triggers a net increase in the percentage of proliferating cardiomyocytes compared to controls. Moreover, there were relationship between cardiomyocytes and fibroblasts proliferation and maternal hemodynamics parameters thus, supporting the hypothesis that the serum of women with HDP may contain factors capable of stimulating cardiac cells in response to the cardiovascular stress-test

Conditions

Cardiovascular Diseases; Pregnancy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

HDP with FGR

Evaluation of sera and ultrasound data on fetal growth and Doppler velocimetry in women with HDP and fetal growth restriction.

No interventions assigned to this group

HDP without FGR

Evaluation of sera and ultrasound data on fetal growth and Doppler velocimetry in women with HDP and without fetal growth restriction.

No interventions assigned to this group

Normotensive

Evaluation of sera and ultrasound data on fetal growth and Doppler velocimetry in normotensive women.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

CASES:

1. Pregnant women affected by HDP

2. Women ≥18 years old

3. Women able to give an informed consent

CONTROLS

1. Uneventful pregnancy of women ≥18 years old

2. Women able to give an informed consent

Exclusion Criteria

1. No informed consent

2. Women <18 years old

3. Presence of other maternal pathologies as viral disease, diabetes

4. Fetal chromosomal/structural anomalies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamara Stampalija, MD

Role: STUDY_DIRECTOR

IRCCS materno infantile Burlo Garofolo

Locations

IRCCS Burlo Garofolo

Trieste, , Italy

Countries

Italy

Central Contacts

Tamara Stampalija, MD

Role: CONTACT

tamara.stampalija@burlo.trieste.it

+390403785486

Facility Contacts

Tamara Stampalija, MD

Role: primary

tamara.stampalija@burlo.trieste.it

+390403785486

Other Identifiers

RC 29/22

Identifier Type: -

Identifier Source: org_study_id