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NCT Number: NCT03949829

The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study

Women with a history of preeclampsia (PE) have increased risk of hypertension and cardiovascular disease (CVD) later in life. Thus, PE is acknowledged as an independent risk factor for CVD, which is the number one cause of death in women in the western part of the world.

Objective:

The purpose of this study is to investigate 1) the prevalence of CVD after PE, 2) which women have the highest risk of developing CVD, 3) when early stages of CVD can be detected in women with previous PE and 4) how CVD progress over time.

Methods:

1000 women with previous PE between the age of 35-55 years will be invited to participate in a follow-up study consisting of anthropometric measurements, blood pressure measurement, urine- and blood samples, cardiac CT-scan and questionnaires. Coronary atherosclerosis will be evaluated using CT imaging.The women will be compared with women with a formerly uncomplicated pregnancy,

Summary:

The study will provide new important information to guide future clinical follow-up, and potentially prevent disease and early death in a large group of women with a history of PE.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

35 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Copenhagen, Denmark

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About this study

Women with a history of preeclampsia (PE) have increased risk of hypertension and cardiovascular disease (CVD) later in life. Thus, PE is acknowledged as an independent risk factor for CVD, which is the number one cause of death in women in the western part of the world. Despite this, solid and uniform guidelines regarding follow-up after a pregnancy complicated by PE are lacking. Little is known about the time-course of the development of CVD and how early stages can be identified in women with previous PE. The link between PE and CVD is well established. However, no large clinical study using cardiac CT-scans exists. Moreover, the study will focus on the time-perspective of the development of CVD in relation to index pregnancy, and this knowledge may prove to be essential to establish solid clinical guidelines addressing timely prevention and treatment.

The purpose of this study is to investigate

  • The prevalence of CVD after PE,
  • Which women have the highest risk of developing CVD
  • When early stages of CVD can be detected in women with previous PE
  • How CVD progress over time.

Thus, we hope to identify a window of opportunity where screening and preventive measures may be relevant and potentially beneficial to these women.

A total of 1000 women with previous PE (aged 35-55 years) will be invited to participate in a clinical follow-up study consisting of anthropometric measurements, blood pressure measurement, urine- and blood samples, cardiac CT-scan (identifying coronary atherosclerotic changes) and questionnaires. These women will be compared to age-matched women, without previous preeclampsia investigated in the Copenhagen General Population Study with an identical CT protocol.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with a history of preeclampsia

Exclusion criteria

  • Severe physical or mental disabilities
  • Lack of ability to speak and/or understand Danish language

Treatment and study plan

Cardiovascular CT

Diagnostic Test

Cardiac and cardiovascular non-contrast and contrast CT

Primary outcomes

  1. Coronary atherosclerosis

    Time frame: Assessed within 30 days of study inclusion

    Presensence of coronary plaque as defined by Cardiac CT

Secondary outcomes

  1. Presence of left bundle branch block

    Time frame: Assessed within 30 days of study inclusion

    Electrocardiographic abnormality

  2. Presence of atrial fibrillation

    Time frame: Assessed within 30 days of study inclusion

    Electrocardiographic abnormality

  3. Presence of T-wave inversion

    Time frame: Assessed within 30 days of study inclusion

    Electrocardiographic abnormality

  4. Presence of left ventricular hypertrophy

    Time frame: Assessed within 30 days of study inclusion

    Electrocardiographic abnormality

  5. Arterial hypertension

    Time frame: Assessed within 30 days of study inclusion

    Presence of elevated blood pressure

  6. Dyspnoe

    Time frame: Assessed within 30 days of study inclusion

    New York Heart Association class

  7. Chest pain

    Time frame: Assessed within 30 days of study inclusion

    Canadian Cardiovascular Society angina pectoris class

Other outcomes

  1. Major cardiovascular events

    Time frame: Assessed 1 year after Cardiac CT imaging

    Composite endpoint of either death, myocardial infarction, heart failure or stroke

Sponsors and collaborators

Lead sponsor

Klaus Fuglsang Kofoed

Other

Collaborators

  • Herlev Hospital

Registry information

Official study title

Cardiovascular Disease After Preeclampsia

Acronym: CPH-PRECIOUS

Important dates

Study start
2019
Primary completion
2020
Study completion
2031
First posted
May 14, 2019
Registry last updated
Dec 12, 2022

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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