The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study

Cardiovascular Diseases Clinical Trial

— CPH-PRECIOUS  

Official title:

Cardiovascular Disease After Preeclampsia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03949829
• Other study ID #: H-18065695
• Status: Active, not recruiting
• Start date: May 20, 2019
• Est. completion date: June 30, 2031

Study information

• Verified date: December 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 921
• Est. completion date: June 30, 2031
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Cardiovascular CT
Cardiac and cardiovascular non-contrast and contrast CT

Locations

Country	Name	City	State
Denmark	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

Sponsors (2)

Lead Sponsor	Collaborator
Klaus Fuglsang Kofoed	Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major cardiovascular events	Composite endpoint of either death, myocardial infarction, heart failure or stroke	Assessed 1 year after Cardiac CT imaging
Primary	Coronary atherosclerosis	Presensence of coronary plaque as defined by Cardiac CT	Assessed within 30 days of study inclusion
Secondary	Presence of left bundle branch block	Electrocardiographic abnormality	Assessed within 30 days of study inclusion
Secondary	Presence of atrial fibrillation	Electrocardiographic abnormality	Assessed within 30 days of study inclusion
Secondary	Presence of T-wave inversion	Electrocardiographic abnormality	Assessed within 30 days of study inclusion
Secondary	Presence of left ventricular hypertrophy	Electrocardiographic abnormality	Assessed within 30 days of study inclusion
Secondary	Arterial hypertension	Presence of elevated blood pressure	Assessed within 30 days of study inclusion
Secondary	Dyspnoe	New York Heart Association class	Assessed within 30 days of study inclusion
Secondary	Chest pain	Canadian Cardiovascular Society angina pectoris class	Assessed within 30 days of study inclusion