Post-Pregnancy Cardio Trial
Completed
- Conditions
- Preeclampsia
- Registration Number
- NCT03313063
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
Preeclampsia is a systemic pregnancy disorder and is associated with an increased cardiovascular risk later in life. This study will characterize myocardial tissue in patients after preeclampsia compared to controls and investigate potential functional and structural changes in the heart of preeclamptic women primarily with two methods: cardiovascular magnetic resonance imaging and echocardiography. A comparison between these two methods, where appropriate, is also envisaged.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 47
Inclusion Criteria
- postpartal window: 0.5 - 20 years
- cases: diagnosis of preeclampsia during the index pregnancy
- controls: age and BMI matched
Exclusion Criteria
- metal implants
- kidney insufficiency (GFR < 30 ml/min/)
- claustrophobia
- contrast medium allergy
- current pregnancy/ lactation
- chronic hypertension (> 140/90)
- diagnosis of previous cardiovascular disease
- body weight over 120 kg
- big tattoos in thorax area
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method any structural or functional change of the heart (combined outcome) 0.5 - 20 years after delivery Combined outcome: myocardial fibrosis, edema, fat infiltrates, inflammation, reduced ejection fraction, hypertrophy
- Secondary Outcome Measures
Name Time Method myocardial fat infiltrates 0.5 - 20 years after delivery myocardial inflammation 0.5 - 20 years after delivery myocardial hypertrophy 0.5 - 20 years after delivery reduced ejection fraction 0.5 - 20 years after delivery myocardial fibrosis 0.5 - 20 years after delivery myocardial edema 0.5 - 20 years after delivery
Trial Locations
- Locations (1)
Experimental and Clinical Research Center (ECRC)
🇩🇪Berlin, Germany