Fetal development of the left ventricular myocardium in left sided congenital heart defects

Fetal development of the left ventricular myocardium in left sided congenital heart defects - DEMY (DEvelopment of the left ventricular MYocardium in utero)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45878

Enrollment

Registered

2019-01-14

Start date

2019-01-17

Completion date

Unknown

Last updated

2026-07-13

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

Conditions

Aortic narrowing

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Pregnant women with: - suspicion of CoA on fetal ultrasound: * ventricular size disproportion (right to left ventricle ratio >1.3) and/or, * great arterial size disproportion (pulmonary to aorta artery ratio >1.3) and/or, * aortic arch hypoplasia - age >=18 years of age - 18-34 weeks of gestational age - singleton or dichorionic twin pregnancy

Exclusion criteria

Exclusion criteria: - Fetal or neonatal diagnosis of other structural defects which could influence myocardial function, except for cardial defects leading to CoA. Cases with a premature closed foramen ovale, persistent vena cava superior sinistra, bicuspid aortic valve or small ventricular septum defect will be included as these conditions are common in CoA. - Fetal chromosomal abnormalities identified by diagnostic testing - Monochorionic twin pregnancy

Design outcomes

Primary

Measure	Time frame
Measurements to assess myocardial development and function: - Global longitudinal strain of the left ventricle obtained by speckle tracking	—

Secondary

Measure	Time frame
Measurements to assess myocardial development and function: - Speckle tracking measurements: global longitudinal strain of the right ventricle, global longitudinal strain rate of the left and right ventricle, global longitudinal velocity in left and right ventricle, regional strain analysis (basal septal, mid septal, apical septal, apical lateral, mid lateral, basal lateral). - cTDI measurements: left ventricle shortening, left ventricle lengthening, inter shortening-lengthening time, inter lengthening-shortening time.	—

Measure

Time frame

Measurements to assess myocardial development and function: - Speckle tracking measurements: global longitudinal strain of the right ventricle, global longitudinal strain rate of the left and right ventricle, global longitudinal velocity in left and right ventricle, regional strain analysis (basal septal, mid septal, apical septal, apical lateral, mid lateral, basal lateral). - cTDI measurements: left ventricle shortening, left ventricle lengthening, inter shortening-lengthening time, inter lengthening-shortening time.

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Countries

Netherlands

Outcome results