Post-Pregnancy Cardio Trial (PPC1)

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

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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13125
    • Experimental and Clinical Research Center (ECRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women between 18 and 50 years of age, 0.5 - 20 years postpartum either with preeclampsia diagnosis during index pregnancy or without pathological findings. Controls are matched to cases based on age and BMI.

Description

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 Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PE; Women with a history or preeclampsia, between 18 - 50 years of age, 0.5 - 20 years postpartum
Control; Age-matched women without any birth complications, between 18 - 50 years of age, 0.5 - 20 years postpartum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
myocardial fibrosis	0.5 - 20 years after delivery
myocardial edema	0.5 - 20 years after delivery
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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; preeclampsia; myocard
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: PPC1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No