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| Name | Class |
|---|---|
| Herlev Hospital | OTHER |
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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.
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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiovascular CT | Diagnostic Test | Cardiac and cardiovascular non-contrast and contrast CT |
| Measure | Description | Time Frame |
|---|---|---|
| Coronary atherosclerosis | Presensence of coronary plaque as defined by Cardiac CT | Assessed within 30 days of study inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of left bundle branch block | Electrocardiographic abnormality | Assessed within 30 days of study inclusion |
| Presence of atrial fibrillation | Electrocardiographic abnormality |
| Measure | Description | Time Frame |
|---|---|---|
| Major cardiovascular events | Composite endpoint of either death, myocardial infarction, heart failure or stroke | Assessed 1 year after Cardiac CT imaging |
Inclusion Criteria
- Women with a history of preeclampsia
Exclusion Criteria
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Damm, MD, DmSc | Department of Obstetrics, Rigshospitalet, University of Copenhagen, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39540300 | Derived | 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. | |
| 38588914 |
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Logistics and patient data protection issues will be explored prior to decision on IPD
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D050197 | Atherosclerosis |
| D002318 | Cardiovascular Diseases |
| D014115 | Toxemia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Blood samples
| Assessed within 30 days of study inclusion |
| Presence of T-wave inversion | Electrocardiographic abnormality | Assessed within 30 days of study inclusion |
| Presence of left ventricular hypertrophy | Electrocardiographic abnormality | Assessed within 30 days of study inclusion |
| Arterial hypertension | Presence of elevated blood pressure | Assessed within 30 days of study inclusion |
| Dyspnoe | New York Heart Association class | Assessed within 30 days of study inclusion |
| Chest pain | Canadian Cardiovascular Society angina pectoris class | Assessed within 30 days of study inclusion |
| Department of Obstetrics, Rigshospitalet | Copenhagen | 2100 | Denmark |
| The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark | Herlev | 2730 | Denmark |
| 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. |
| 35680182 | 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. |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007239 | Infections |