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.
Condition or disease | Intervention/treatment |
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Pre-Eclampsia Atherosclerosis Cardiovascular Diseases Heart Disease in Women | Diagnostic Test: Cardiovascular CT |
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
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 [Patient Registry] |
Actual Enrollment : | 921 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 10 Years |
Official Title: | Cardiovascular Disease After Preeclampsia |
Actual Study Start Date : | May 20, 2019 |
Actual Primary Completion Date : | January 30, 2021 |
Estimated Study Completion Date : | June 30, 2031 |
Tracking Information | |||||
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First Submitted Date | May 8, 2019 | ||||
First Posted Date | May 14, 2019 | ||||
Last Update Posted Date | May 18, 2021 | ||||
Actual Study Start Date | May 20, 2019 | ||||
Actual Primary Completion Date | January 30, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Coronary atherosclerosis [ Time Frame: Assessed within 30 days of study inclusion ] Presensence of coronary plaque as defined by Cardiac CT
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures |
Major cardiovascular events [ Time Frame: Assessed 1 year after Cardiac CT imaging ] Composite endpoint of either death, myocardial infarction, heart failure or stroke
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title | The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study | ||||
Official Title | Cardiovascular Disease After Preeclampsia | ||||
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. |
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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
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. |
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Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | 10 Years | ||||
Biospecimen | Retention: Samples With DNA Description:
Blood samples
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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. | ||||
Condition |
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Intervention | Diagnostic Test: Cardiovascular CT
Cardiac and cardiovascular non-contrast and contrast CT
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Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Actual Enrollment |
921 | ||||
Original Estimated Enrollment |
1000 | ||||
Estimated Study Completion Date | June 30, 2031 | ||||
Actual Primary Completion Date | January 30, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria - Women with a history of preeclampsia Exclusion Criteria
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Sex/Gender |
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Ages | 35 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Denmark | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03949829 | ||||
Other Study ID Numbers | H-18065695 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Klaus Fuglsang Kofoed, Rigshospitalet, Denmark | ||||
Study Sponsor | Klaus Fuglsang Kofoed | ||||
Collaborators | Herlev Hospital | ||||
Investigators |
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PRS Account | Rigshospitalet, Denmark | ||||
Verification Date | May 2021 |