The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study (CPH-PRECIOUS)

Cardiovascular Disease After Preeclampsia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Atherosclerosis; Pre-Eclampsia; Heart Disease in Women
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Actual): 921

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
  • Copenhagen, Denmark, 2100
    • Department of Obstetrics, Rigshospitalet
  • Herlev, Denmark, 2730
    • The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coronary atherosclerosis	Presensence of coronary plaque as defined by Cardiac CT	Assessed within 30 days of study inclusion

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Klaus Fuglsang Kofoed
• Collaborators: Herlev Hospital
• Investigators: Study Chair: Peter Damm, MD, DmSc, Department of Obstetrics, Rigshospitalet, University of Copenhagen, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Anticipated): June 30, 2031

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 11, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Pre- eclampsia; Heart disease in women
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pregnancy Complications; Hypertension, Pregnancy-Induced; Heart Diseases; Cardiovascular Diseases; Atherosclerosis; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: H-18065695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Logistics and patient data protection issues will be explored prior to decision on IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No