CPH-PRECIOUS: The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study

Sponsor

Klaus Fuglsang Kofoed (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03949829

Collaborator

Herlev Hospital (Other)

921

Enrollment

Locations

145.3

Anticipated Duration (Months)

307

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-Eclampsia Atherosclerosis Cardiovascular Diseases Heart Disease in Women	Diagnostic Test: Cardiovascular CT

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

The prevalence of CVD after PE,
Which women have the highest risk of developing CVD
When early stages of CVD can be detected in women with previous PE
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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

921 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Cardiovascular Disease After Preeclampsia

Actual Study Start Date :

May 20, 2019

Actual Primary Completion Date :

Jan 30, 2021

Anticipated Study Completion Date :

Jun 30, 2031

Outcome Measures

Primary Outcome Measures

Coronary atherosclerosis [Assessed within 30 days of study inclusion]
Presensence of coronary plaque as defined by Cardiac CT

Secondary Outcome Measures

Presence of left bundle branch block [Assessed within 30 days of study inclusion]
Electrocardiographic abnormality
Presence of atrial fibrillation [Assessed within 30 days of study inclusion]
Electrocardiographic abnormality
Presence of T-wave inversion [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
Dyspnoe [Assessed within 30 days of study inclusion]
New York Heart Association class
Chest pain [Assessed within 30 days of study inclusion]
Canadian Cardiovascular Society angina pectoris class

Other Outcome Measures

Major cardiovascular events [Assessed 1 year after Cardiac CT imaging]
Composite endpoint of either death, myocardial infarction, heart failure or stroke

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen	Copenhagen	Denmark	2100
2	Department of Obstetrics, Rigshospitalet	Copenhagen	Denmark	2100
3	The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark	Herlev	Denmark	2730