The Right Heart During and After Pregnancy - an Echocardiographic Study (EVA)

Das Rechte Herz in Der Schwangerschaft. Echokardiographische Verlaufskontrollen Des Rechten Herzens während Und Nach Der Schwangerschaft.

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: Diagnostic test: echocardiography

Detailed Description

A lot of lung diseases affect the heart, too - especially the right heart. Well known examples are pulmonary embolism or pulmonary hypertension. But rather unknown is the fact, that right heart function presents as a prognostic parameter in a lot of (left heart) diseases, for example myocardial infarction, atrial fibrillation, left heart failure, but also in chronic obstructive pulmonary disease (COPD) or may be even diabetes mellitus. Since the left part of the heart has been studied by researchers more than fifty years, the right heart has moved into scientific focus not long ago.

The tool of choice to examine the living heart is echocardiography. There are no relevant risks or complications.

During an echocardiographic examination a lot of parameters are collected. To judge data in a clinical way reference values belonging to healthy persons are essential. Those values are highly dependant on sex, body size, age etc.

Since pregnancy changes a lot in the human body, reference values from non pregnant woman of same age (published by American society of echocardiography and European Association of Echocardiography) are presumably not representative. So the investigators want to establish echocardiographic reference values of the right heart for pregnant women. Therefore an echocardiographic examination will be applied within each trimester of pregnancy and after delivery. As side arms the investigators want to explore, whether illness of either fetus or mother is connected with right heart affection.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Gero Bunniger; Phone Number: +49641 985 56082; Email: gero.bunniger@innere.med.uni-giessen.de
• Study Contact Backup: Name: Henning Gall, Prof., MD; Phone Number: +49 641 985 57030; Email: henning.gall@innere.med.uni-giessen.de

Study Locations

• Germany
  • Hesse
    • Gießen, Hesse, Germany, 35392
      • Recruiting
      • University of Gießen
      • Sub-Investigator: Gero Bunniger
      • Sub-Investigator: Manuel Richter, MD
      • Sub-Investigator: Natascha Sommer, PhD
      • Sub-Investigator: Frank Oehmke, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women over 18 years, actual mean age is 33y

Description

Inclusion Criteria:

• pregnant
• 18years or older

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: parallel EKG
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; 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.; Other Names: parallel EKG
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; 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.; Other Names: parallel EKG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gero Bunniger
• Investigators: Principal Investigator: Henning Gall, Prof., MD, Pulmology, Department of pulmonal Hypertension

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Anticipated): November 2, 2023
• Study Completion (Anticipated): November 2, 2024

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: echocardiography; pregnancy; right heart; reference values
• Other Study ID Numbers: 130/17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No