The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study

NCT03949829 | Active Not Recruiting

• 1 other identifier: H-18065695
• Study Type: observational
• Target: 921
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Pre- eclampsia; Heart disease in women

Outcome Measures

Primary Outcomes (1)

• Coronary atherosclerosis

  Presensence of coronary plaque as defined by Cardiac CT

  Assessed within 30 days of study inclusion

Secondary Outcomes (7)

• Presence of left bundle branch block

  Assessed within 30 days of study inclusion

• Presence of atrial fibrillation

  Assessed within 30 days of study inclusion

• Presence of T-wave inversion

  Assessed within 30 days of study inclusion

• Presence of left ventricular hypertrophy

  Assessed within 30 days of study inclusion

• Arterial hypertension

  Assessed within 30 days of study inclusion

Other Outcomes (1)

• Major cardiovascular events

  Assessed 1 year after Cardiac CT imaging

Interventions

Cardiovascular CT DIAGNOSTIC_TEST

Cardiac and cardiovascular non-contrast and contrast CT

Eligibility Criteria

• Age: 35 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• \- Women with a history of preeclampsia

You may not qualify if:

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

Sponsors & Collaborators

• Klaus Fuglsang Kofoed: lead
• Herlev Hospital: collaborator

Study Sites (3)

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

Copenhagen, 2100, Denmark

Location

Department of Obstetrics, Rigshospitalet

Copenhagen, 2100, Denmark

Location

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

Herlev, 2730, Denmark

Location

Related Publications (3)

• 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.

  PMID: 39540300 DERIVED

• 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.

  PMID: 38588914 DERIVED

• 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.

  PMID: 35680182 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Pre-Eclampsia; Atherosclerosis; Cardiovascular Diseases; Toxemia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infections

Study Officials

• Peter Damm, MD, DmSc

  Department of Obstetrics, Rigshospitalet, University of Copenhagen, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associated Research Professor

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 14, 2019
• Study Start: May 20, 2019
• Primary Completion: March 30, 2020
• Study Completion (Estimated): June 30, 2031
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

DK (3)