The Right Heart During and After Pregnancy - an Echocardiographic Study

Pregnancy Related Clinical Trial

— EVA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03402971
• Other study ID #: 130/17
• Status: Recruiting
• Start date: November 2, 2017
• Est. completion date: November 2, 2024

Study information

• Verified date: April 2021
• Source: University of Giessen
• Contact: Gero Bunniger
• Phone: +49641 985 56082
• Email: gero.bunniger[@]innere.med.uni-giessen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2, 2024
• Est. primary completion date: November 2, 2023
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pregnant
• 18years or older

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
Germany	University of Gießen	Gießen	Hesse

Sponsors (1)

Lead Sponsor	Collaborator
Gero Bunniger

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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