The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study

NCT ID: NCT03949829

Last Updated: 2022-12-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 921 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2031-06-30

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.

Conditions

Pre-Eclampsia; Atherosclerosis; Cardiovascular Diseases; Heart Disease in Women

Keywords

Pre- eclampsia; Heart disease in women

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

Cardiovascular CT

Cardiac and cardiovascular non-contrast and contrast CT

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: collaborator

Klaus Fuglsang Kofoed

OTHER

Sponsor Role: lead

Responsible Party

Klaus Fuglsang Kofoed

Clinical Associated Research Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter Damm, MD, DmSc

Role: STUDY_CHAIR

Department of Obstetrics, Rigshospitalet, University of Copenhagen, Denmark

Locations

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

Copenhagen, , Denmark

Department of Obstetrics, Rigshospitalet

Copenhagen, , Denmark

The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark

Herlev, , Denmark

Countries

Denmark

References

Hauge MG, Damm P, Kofoed KF, Moller ELR, Lopez AG, Ersboll AS, Johansen M, Sigvardsen PE, Pham MHC, Goetze JP, Fuchs A, Kuhl JT, Nordestgaard BG, Kober LV, Gustafsson F, Linde JJ. Left Ventricular Hypertrophy in Women With a History of Preeclampsia. Hypertension. 2025 May;82(5):774-783. doi: 10.1161/HYPERTENSIONAHA.124.23497. Epub 2024 Nov 14.

Reference Type: DERIVED

PMID: 39540300 (View on PubMed)

Hauge MG, Linde JJ, Kofoed KF, Ersboll AS, Johansen M, Sigvardsen PE, Fuchs A, Mikkelsen AP, Gustafsson F, Damm P. Early-onset vs late-onset preeclampsia and risk of coronary atherosclerosis later in life: a clinical follow-up study. Am J Obstet Gynecol MFM. 2024 May;6(5):101371. doi: 10.1016/j.ajogmf.2024.101371. Epub 2024 Apr 6.

Reference Type: DERIVED

PMID: 38588914 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35680182 (View on PubMed)

Other Identifiers

H-18065695

Identifier Type: -

Identifier Source: org_study_id