Post-Pregnancy Cardio Trial

Preeclampsia Clinical Trial

— PPC1  

Official title:

Myocardial Characterization With Magnetic Resonance Imaging in Patients After Preeclampsia (Pilot Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313063
• Other study ID #: PPC1
• Status: Completed
• Start date: August 28, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
Germany	Experimental and Clinical Research Center (ECRC)	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	any structural or functional change of the heart (combined outcome)	Combined outcome: myocardial fibrosis, edema, fat infiltrates, inflammation, reduced ejection fraction, hypertrophy	0.5 - 20 years after delivery
Secondary	myocardial fibrosis		0.5 - 20 years after delivery
Secondary	myocardial edema		0.5 - 20 years after delivery
Secondary	myocardial fat infiltrates		0.5 - 20 years after delivery
Secondary	myocardial inflammation		0.5 - 20 years after delivery
Secondary	myocardial hypertrophy		0.5 - 20 years after delivery
Secondary	reduced ejection fraction		0.5 - 20 years after delivery