Clinical trial NCT03949829: The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Official title: Cardiovascular Disease After Preeclampsia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pre-Eclampsia
Atherosclerosis
Cardiovascular Diseases
Heart Disease in Women
Keywords: Pre- eclampsia
Heart disease in women
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
First posted: 2019-05-14
Enrollment: 921
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 1000 women with previous preeclampsia will be invited to participate in a post-pregnancy clinical cardiovascular CT follow-up study. These women will be compared to age-matched women, without previous preeclampsia investigated in the Copenhagen General Population Study with an identical CT protocol.

Brief summary: 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.

Detailed description: 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

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
4. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Coronary atherosclerosis
timeFrame: Assessed within 30 days of study inclusion
Secondary outcomes:
measure: Presence of left bundle branch block
timeFrame: Assessed within 30 days of study inclusion
measure: Presence of atrial fibrillation
timeFrame: Assessed within 30 days of study inclusion
measure: Presence of T-wave inversion
timeFrame: Assessed within 30 days of study inclusion
measure: Presence of left ventricular hypertrophy
timeFrame: Assessed within 30 days of study inclusion
measure: Arterial hypertension
timeFrame: Assessed within 30 days of study inclusion
measure: Dyspnoe
timeFrame: Assessed within 30 days of study inclusion
measure: Chest pain
timeFrame: Assessed within 30 days of study inclusion
Other outcomes:
measure: Major cardiovascular events
timeFrame: Assessed 1 year after Cardiac CT imaging
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
city: Copenhagen
country: Denmark
facility: Department of Obstetrics, Rigshospitalet
city: Herlev
country: Denmark
facility: The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark
Study officials:
affiliation: Department of Obstetrics, Rigshospitalet, University of Copenhagen, Denmark
name: Peter Damm, MD, DmSc
role: STUDY_CHAIR
References:
citation: Hauge MG, Damm P, Kofoed KF, Ersboll AS, Johansen M, Sigvardsen PE, Moller MB, Fuchs A, Kuhl JT, Nordestgaard BG, Kober LV, Gustafsson F, Linde JJ. Early Coronary Atherosclerosis in Women With Previous Preeclampsia. J Am Coll Cardiol. 2022 Jun 14;79(23):2310-2321. doi: 10.1016/j.jacc.2022.03.381.