Clinical trial NCT03402971: The Right Heart During and After Pregnancy - an Echocardiographic Study
Official title: Das Rechte Herz in Der Schwangerschaft. Echokardiographische Verlaufskontrollen Des Rechten Herzens während Und Nach Der Schwangerschaft.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Related
Keywords: right heart
pregnancy
echocardiography
reference values
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women over 18 years, actual mean age is 33y

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.

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.

Eligibility criteria: Inclusion Criteria:

* pregnant
* 18years or older

Exclusion Criteria:

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

Primary outcomes:
measure: change in right ventricular (RV) enddiastolic diameter basal
timeFrame: 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
measure: change in RV enddiastolic diameter mid-cavitiy
timeFrame: 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
measure: change in RV enddiastolic diameter longitudinal
timeFrame: 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
measure: change in right ventricular outflow tract (RVOT) distal
timeFrame: 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
measure: change in right atrial (RA) endsystolic area
timeFrame: 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
measure: change in RV wall thickness
timeFrame: 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
measure: change in tricuspid annular plane systolic excursion (TAPSE)
timeFrame: 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
measure: change in S' velocity
timeFrame: 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
measure: change in tricuspid E/A ratio
timeFrame: 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
measure: change in tricuspid E/e' ratio
timeFrame: 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
measure: change in right index of myocardial performance (RIMP)
timeFrame: 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
measure: change in inferior vena cava (IVC) diameter at end-expiration
timeFrame: 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
measure: change in inferior vena cava (IVC) diameter with sniff test.
timeFrame: 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
measure: change in tricuspid regurgitation peak velocity
timeFrame: 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
measure: change in RV outflow tract acceleration time (RVOT-AT)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University of Gießen
state: Hesse
Study officials:
affiliation: Pulmology, Department of pulmonal Hypertension
name: Henning Gall, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: