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Completed

NCT Number: NCT03313063

Post-Pregnancy Cardio Trial

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Experimental and Clinical Research Center (ECRC)

Berlin, 13125, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. any structural or functional change of the heart (combined outcome)

    Time frame: 0.5 - 20 years after delivery

    Combined outcome: myocardial fibrosis, edema, fat infiltrates, inflammation, reduced ejection fraction, hypertrophy

Secondary outcomes

  1. myocardial fibrosis

    Time frame: 0.5 - 20 years after delivery

  2. myocardial edema

    Time frame: 0.5 - 20 years after delivery

  3. myocardial fat infiltrates

    Time frame: 0.5 - 20 years after delivery

  4. myocardial inflammation

    Time frame: 0.5 - 20 years after delivery

  5. myocardial hypertrophy

    Time frame: 0.5 - 20 years after delivery

  6. reduced ejection fraction

    Time frame: 0.5 - 20 years after delivery

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: PPC1

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2017
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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