The Right Heart During and After Pregnancy - an Echocardiographic Study

NCT03402971 | Unknown

• 1 other identifier: 130/17
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal is to establish echocardiographic reference values of the right heart for pregnant women, assuming they differ significantly from those of non pregnant women of same age. Therefore the investigators will use existing reference values published by American society of echocardiography and European Association of Echocardiography. As side arms the investigators want to explore, whether illness of either fetus or mother is connected with right heart affection.

Conditions

Pregnancy Related

Keywords

right heart; pregnancy; echocardiography; reference values

Outcome Measures

Primary Outcomes (15)

• change in right ventricular (RV) enddiastolic diameter basal

  The investigators measure right ventricular (RV) enddiastolic diameter basal (unit: mm), via echocardiography in apical 4 Chamber view, EKG-controlled.

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

• change in RV enddiastolic diameter mid-cavitiy

  The investigators measure right ventricular RV enddiastolic diameter mid-cavity (unit: mm), via echocardiography in apical 4 Chamber view, EKG-controlled.

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

• change in RV enddiastolic diameter longitudinal

  The investigators measure right ventricular RV enddiastolic diameter longitudinal (unit: mm), via echocardiography in apical 4 Chamber view, EKG-controlled.

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

• change in right ventricular outflow tract (RVOT) distal

  The investigators measure RVOT distal (unit: mm), via echocardiography in parasternal short-axis view, EKG-controlled.

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

• change in right atrial (RA) endsystolic area

  The investigators measure RA endsystolic area (unit: cm²), via echocardiography in apical 4 Chamber view, EKG-controlled.

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

• change in RV wall thickness

  The investigators measure RV wall thickness (unit: mm), via echocardiography in subcostal view, EKG-controlled. RV wall \>5mm indicates RV hypertrophy.

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

• change in tricuspid annular plane systolic excursion (TAPSE)

  The investigators measure TAPSE (unit: mm), via echocardiography in apical 4 Chamber view + M-Mode at lateral tricuspid annulus, EKG-controlled. TAPSE is a parameter describing systolic RV-function.

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

• change in S' velocity

  The investigators measure S' velocity (unit: cm/sec), via echocardiography in apical 4 Chamber view + pulsed tissue Doppler velocity of the lateral tricuspid annulus, EKG-controlled. S' is a parameter describing systolic RV-function.

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

• change in tricuspid E/A ratio

  The investigators measure tricuspidal E/A ratio (unit: no unit), via echocardiography in apical 4 Chamber view + pulsed wave doppler over tricuspid inflow, EKG-controlled. Tricuspid E/A ratio is a parameter describing diastolic RV-function.

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

• change in tricuspid E/e' ratio

  The investigators measure tricuspid E/e' ratio (unit: no unit), via echocardiography in apical 4 Chamber view + pulsed wave doppler over tricuspid inflow + pulsed tissue Doppler velocity of the lateral tricuspid annulus, EKG-controlled. Tricuspid E/e' ratio is a parameter describing diastolic RV-function.

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

• change in right index of myocardial performance (RIMP)

  The investigators measure RIMP (unit: no unit), via echocardiography in apical 4 Chamber view + pulsed tissue Doppler velocity of the lateral tricuspid annulus, EKG-controlled. RIMP is calculated (isovolumic contraction time + isovolumic relaxation time) devided by (ejection time). RIMP is a parameter describing systolic RV-function.

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

• change in inferior vena cava (IVC) diameter at end-expiration

  The investigators measure IVC (unit: mm) via echocardiography subcostal or IVC view at end-expiration. IVC diameter correlates with central venous pressure.

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

• change in inferior vena cava (IVC) diameter with sniff test.

  The investigators measure IVC (unit: mm) via echocardiography subcostal or IVC view at forced inspiration. IVC diameter correlates with central venous pressure.

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

• change in tricuspid regurgitation peak velocity

  The investigators measure tricuspid regurgitation peak velocity (unit: m/sec) via echocardiography in apical 4 Chamber view + continuous wave doppler over tricuspid inflow respectively tricuspid regurgitation, if there is a tricuspid insufficiency, EKG-controlled. Tricuspid regurgitation peak velocity correlates with systolic pulmonary artery pressure (sPAP).

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

• change in RV outflow tract acceleration time (RVOT-AT)

  The investigators measure RVOT-AT (unit: msec) via echocardiography in parasternal short-axis view + pulsed wave doppler over pulmonal valve, EKG-controlled. RVOT-AT correlates with systolic pulmonary artery pressure (sPAP).

  first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery

Study Arms (3)

healthy pregnant+healthy fetus

healthy pregnant women with suspected healthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery

Diagnostic Test: echocardiography

non healthy pregnant

non healthy women with suspected healthy or unhealthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery

Diagnostic Test: echocardiography

non healthy fetus

healthy or non healthy pregnant women with suspected non healthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery

Diagnostic Test: echocardiography

Interventions

echocardiography DIAGNOSTIC_TEST

echocardiography focused on right heart: Parameters include RV enddiastolic diameter basal, mid-cavity and longitudinal, RVOT distal, pulmonal outflow AT and AT/ET, endsystolic RA area. RV wall thickness, TAPSE, S', tricuspidal E/A, E/e', RIMP. V. Cava to estimate CVP and sPAP.

Also known as: parallel EKG

healthy pregnant+healthy fetus; non healthy fetus; non healthy pregnant

Eligibility Criteria

• Age: 18 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women over 18 years, actual mean age is 33y

You may qualify if:

• pregnant
• years or older

You may not qualify if:

• acute illness demanding instant therapy
• poor or none sonographic results

Sponsors & Collaborators

• Gero Bunniger: lead

Study Sites (1)

University of Gießen

Giessen, Hesse, 35392, Germany

RECRUITING

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Henning Gall, Prof., MD

  Pulmology, Department of pulmonal Hypertension

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gero Bunniger

CONTACT

+49641 985 56082; gero.bunniger@innere.med.uni-giessen.de

Henning Gall, Prof., MD

CONTACT

+49 641 985 57030; henning.gall@innere.med.uni-giessen.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 18, 2018
• Study Start: November 2, 2017
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2024
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

DE (1)