Correlation of Right Atrial Strain With Pulmonary Hypertension, Right Ventricular Function And Outcome In Pediatric Patients

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 1 month to 12 years
• All sexes
• Child

Study population: As described above.

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Pulmonary Hypertension

Being tested

Transthoracic and transesophageal echocardiography

Medical subject headings

Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Transthoracic and transesophageal echocardiographyDiagnostic test

  Also called Measurement of Pulmonary arterial pressure

  After induction of anaesthesia and stabilization of hemodynamics, transthoracic echocardiography will be done on a GE Vivid e9 workstation (GE Vingmed, Horton, Norway) with MS5 transthoracic probe with synchronized ECG.

  From TTE the following views and measurements will be acquired :

  • Apical four chamber (A4C) view
  • Apical two chamber view (A2C) view
  • Right ventricle (RV) focused A4C view
  • Right ventricular systolic pressure (RVSP)
  • Pulmonary arterial acceleration time (PAAT),
  • Tricuspid annular plane systolic excursion (TAPSE),
  • Tricuspid annular plane systolic velocity (s'),
  • Right ventricular fractional area change (RV FAC)
  • RV free wall strain,
  • RV myocardial performance index (MPI),
  • RV isovolumic relaxation time (IVRT),
  • RV isovolumic acceleration time (IVA)

  Invasive PA pressure measurement will be done after surgical exposure with a fine needle and a zeroed transducer by the Surgeon.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Correlation of right atrial strain measured by two-dimensional speckle tracking echocardiography with intraoperatively measured systolic pulmonary artery pressures.

   RA strain estimation will be done from the TTE images in RV focused A4C view, tracing the endocardial border from tricuspid annulus to tricuspid annulus along RA lateral wall to roof to septal wall.

   After optimizing the region of interest and automated speckle tracking for longitudinal strain and the following parameters will be measured :

   • RA reservoir strain : difference of the strain value at tricuspid valve opening minus ventricular end-diastole (positive value).
   • RA conduit strain : difference of the strain value at the onset of atrial contraction minus tricuspid valve opening (negative value).
   • RA contractile strain : difference of the strain value at ventricular end- diastole minus onset of atrial contraction (negative value).

   Measured: For RA strain : after induction of anesthesia, before CPB institution. For pulmonary artery pressures, after induction of anesthesia, before CPB institution, and 10 min after separation from CPB, before sternal closure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted26 Jan 2023
2. Study start1 Jan 2021
3. Primary completion31 Jan 2023 (estimated)
4. Study completion15 Feb 2023 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.