The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study

Active, not recruiting

• Conditions: Cardiovascular Diseases; Heart Disease in Women; Pre-Eclampsia; Atherosclerosis

• Registration Number: NCT03949829
• Lead Sponsor: Klaus Fuglsang Kofoed

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.

Study Timeline

• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-11
• Study First Posted: 2019-05-14
• Study Start: 2019-05-20
• Primary Completion: 2020-03-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-12
• Study Completion: 2031-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 921

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coronary atherosclerosis	Assessed within 30 days of study inclusion	Presensence of coronary plaque as defined by Cardiac CT

Secondary Outcome Measures

Name	Time	Method
Presence of left bundle branch block	Assessed within 30 days of study inclusion	Electrocardiographic abnormality
Dyspnoe	Assessed within 30 days of study inclusion	New York Heart Association class
Presence of T-wave inversion	Assessed within 30 days of study inclusion	Electrocardiographic abnormality
Presence of atrial fibrillation	Assessed within 30 days of study inclusion	Electrocardiographic abnormality
Presence of left ventricular hypertrophy	Assessed within 30 days of study inclusion	Electrocardiographic abnormality
Arterial hypertension	Assessed within 30 days of study inclusion	Presence of elevated blood pressure
Chest pain	Assessed within 30 days of study inclusion	Canadian Cardiovascular Society angina pectoris class

Trial Locations

Locations (3)

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