Endothelial dysfunction and pregnancy complications in women with congenital heart disease: an addendum to the ZAHARA-II study (ZAHARED study)

Endothelial dysfunction and pregnancy complications in women with congenital heart disease: an addendum to the ZAHARA-II study (ZAHARED study) - ZAHARED

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31812

Enrollment

195

Registered

2007-10-11

Start date

2007-09-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital heart disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All pregnant patients with a congenital heart anomaly presenting before 20 weeks of gestation in one of the participating medical centres; 60 healthy controls

Exclusion criteria

Exclusion criteria: Congenital heart disease: no exclusion criteria. Healthy women: Women who are on chronic medication; women who are under specialist control for chronic disease; drug addicts and smokers

Design outcomes

Primary

Measure	Time frame
- Change in cardiac parameters: Significant deterioration in size/function of subpulmonary or systemic ventricle; aggravation of valve regurgitation >= 1 grade; persistent (1 year) significant aggravation of valve stenosis; significant elevation of NT-pro-BNP, compared to healthy controls - Difference of uteroplacental flow parameters between healthy controls and CHD patients: pulsatility index, % persistent diastolic notching - Composite endpoint of cardiac complications - Composite endpoint of obstetric complications - Composite endpoint of neonatal complications - Composite endpoint of uteroplacental flow related complications (PIH, pre-eclampsia, eclampsia, intrauterine growth retardation, small for gestational age birth weigt, premature delivery, neonatal mortality). endpoints for the substudy: -Change in endothelial function parameters in women with CHD with the same parameters in healthy pregnant women during and after pregnancy. -Change in endothelial function parameters in these women in relation to uteroplacental flow parameters and to pregnancy outcome (cardiac, obetetric and neonatal complications). -Change in endothelial function parameters in these women to underlying disease, genetic profile and cardiac function (nT-pro-BNP, echocardiography, pre-pregnancy and post-pregnancy exercise capacity).	—

Measure

Time frame

- Change in cardiac parameters: Significant deterioration in size/function of subpulmonary or systemic ventricle; aggravation of valve regurgitation >= 1 grade; persistent (1 year) significant aggravation of valve stenosis; significant elevation of NT-pro-BNP, compared to healthy controls - Difference of uteroplacental flow parameters between healthy controls and CHD patients: pulsatility index, % persistent diastolic notching - Composite endpoint of cardiac complications - Composite endpoint of obstetric complications - Composite endpoint of neonatal complications - Composite endpoint of uteroplacental flow related complications (PIH, pre-eclampsia, eclampsia, intrauterine growth retardation, small for gestational age birth weigt, premature delivery, neonatal mortality). endpoints for the substudy: -Change in endothelial function parameters in women with CHD with the same parameters in healthy pregnant women during and after pregnancy. -Change in endothelial function parameters in these women in relation to uteroplacental flow parameters and to pregnancy outcome (cardiac, obetetric and neonatal complications). -Change in endothelial function parameters in these women to underlying disease, genetic profile and cardiac function (nT-pro-BNP, echocardiography, pre-pregnancy and post-pregnancy exercise capacity).

—

Secondary

Measure	Time frame
Change in exercise capacity (exercise test) 1 year post pregnancy compared to pre-pregnancy. Deterioration of NYHA class during / after pregnancy in CHD patients, compared to healthy women. For the substudy: To find genes that cause ED and pregnancy complications in women with CHD.	—

Countries

Netherlands

Outcome results