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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study

Cardiovascular Disease After Preeclampsia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03949829
Acronym
CPH-PRECIOUS
Enrollment
921
Registered
2019-05-14
Start date
2019-05-20
Completion date
2031-06-30
Last updated
2022-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pre- eclampsia, Heart disease in women

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.

Interventions

DIAGNOSTIC_TESTCardiovascular CT

Cardiac and cardiovascular non-contrast and contrast CT

Sponsors

Herlev Hospital
CollaboratorOTHER
Klaus Fuglsang Kofoed
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Coronary atherosclerosisAssessed within 30 days of study inclusionPresensence of coronary plaque as defined by Cardiac CT

Secondary

MeasureTime frameDescription
Presence of left bundle branch blockAssessed within 30 days of study inclusionElectrocardiographic abnormality
Presence of atrial fibrillationAssessed within 30 days of study inclusionElectrocardiographic abnormality
Presence of T-wave inversionAssessed within 30 days of study inclusionElectrocardiographic abnormality
Arterial hypertensionAssessed within 30 days of study inclusionPresence of elevated blood pressure
DyspnoeAssessed within 30 days of study inclusionNew York Heart Association class
Chest painAssessed within 30 days of study inclusionCanadian Cardiovascular Society angina pectoris class
Presence of left ventricular hypertrophyAssessed within 30 days of study inclusionElectrocardiographic abnormality

Other

MeasureTime frameDescription
Major cardiovascular eventsAssessed 1 year after Cardiac CT imagingComposite endpoint of either death, myocardial infarction, heart failure or stroke

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026