Pre-EclampsiaCPH-PRECIOUSNCT03949829
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
An observational study of Pre-Eclampsia and Atherosclerosis, run by Klaus Fuglsang Kofoed at 3 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Pre-Eclampsia, Atherosclerosis, Cardiovascular Diseases
- What is being tested?
- Cardiovascular CT
- How many people
- 921 participants
- Where
- 3 sitesDenmark
- Study dates
- 20 May 2019to 30 Jun 2031
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Women with a history of preeclampsia
Who cannot join
- Severe physical or mental disabilities
- Lack of ability to speak and/or understand Danish language
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, 2100
Department of Obstetrics, Rigshospitalet
Copenhagen, 2100
The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark
Herlev, 2730
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- Cardiovascular CT
- Keywords
- Pre- eclampsia, Heart disease in women
- Medical subject headings
- Pre-Eclampsia, Atherosclerosis, Cardiovascular Diseases, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular CTDiagnostic test
Cardiac and cardiovascular non-contrast and contrast CT
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary atherosclerosis
Presensence of coronary plaque as defined by Cardiac CT
Measured: Assessed within 30 days of study inclusion
Secondary outcomes (7)
Presence of left bundle branch block
Electrocardiographic abnormality
Measured: Assessed within 30 days of study inclusion
Presence of atrial fibrillation
Electrocardiographic abnormality
Measured: Assessed within 30 days of study inclusion
Presence of T-wave inversion
Electrocardiographic abnormality
Measured: Assessed within 30 days of study inclusion
Presence of left ventricular hypertrophy
Electrocardiographic abnormality
Measured: Assessed within 30 days of study inclusion
Arterial hypertension
Presence of elevated blood pressure
Measured: Assessed within 30 days of study inclusion
Dyspnoe
New York Heart Association class
Measured: Assessed within 30 days of study inclusion
Chest pain
Canadian Cardiovascular Society angina pectoris class
Measured: Assessed within 30 days of study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start20 May 2019
- Primary completion30 Mar 2020
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 921 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Klaus Fuglsang Kofoed
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital
- Responsible party
- Sponsor-investigator, Klaus Fuglsang Kofoed, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Peter Damm, MD, DmSc, Study chair, Department of Obstetrics, Rigshospitalet, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949829
- Sponsor's protocol ID
- H-18065695
- Acronym
- CPH-PRECIOUS
- Status last verified
- Nov 2026
- First submitted
- 8 May 2019
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Logistics and patient data protection issues will be explored prior to decision on IPD
Publications
Hauge MG, Damm P, Kofoed KF, Moller ELR, Lopez AG, Ersboll AS, Johansen M, Sigvardsen PE, Pham MHC, Goetze JP, Fuchs A, Kuhl JT, Nordestgaard BG, Kober LV, Gustafsson F, Linde JJ. Left Ventricular Hypertrophy in Women With a History of Preeclampsia. Hypertension. 2025 May;82(5):774-783. doi: 10.1161/HYPERTENSIONAHA.124.23497. Epub 2024 Nov 14.
PubMed 39540300Hauge MG, Linde JJ, Kofoed KF, Ersboll AS, Johansen M, Sigvardsen PE, Fuchs A, Mikkelsen AP, Gustafsson F, Damm P. Early-onset vs late-onset preeclampsia and risk of coronary atherosclerosis later in life: a clinical follow-up study. Am J Obstet Gynecol MFM. 2024 May;6(5):101371. doi: 10.1016/j.ajogmf.2024.101371. Epub 2024 Apr 6.
PubMed 38588914Hauge 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.
PubMed 35680182
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Disease After Preeclampsia
- ClinicalTrials.gov ID
- NCT03949829
- Acronym / sponsor ID
- CPH-PRECIOUS / H-18065695
- Keywords
- Pre- eclampsia, Heart disease in women
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 921 participants (actual)
- Lead sponsor
- Klaus Fuglsang KofoedUniversity, hospital or other
- Collaborators
- Herlev Hospital
- Study start
- 20 May 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Women with a history of preeclampsia
Key exclusion criteria (2 listed)
- Severe physical or mental disabilities
- Lack of ability to speak and/or understand Danish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular CTCardiac and cardiovascular non-contrast and contrast CT | Diagnostic test | – |
Primary outcome
Coronary atherosclerosis
Time frame: Assessed within 30 days of study inclusion
Presensence of coronary plaque as defined by Cardiac CT
7 secondary outcomes
Presence of left bundle branch block
Time frame: Assessed within 30 days of study inclusion
Presence of atrial fibrillation
Time frame: Assessed within 30 days of study inclusion
Presence of T-wave inversion
Time frame: Assessed within 30 days of study inclusion
Presence of left ventricular hypertrophy
Time frame: Assessed within 30 days of study inclusion
Arterial hypertension
Time frame: Assessed within 30 days of study inclusion
Dyspnoe
Time frame: Assessed within 30 days of study inclusion
Chest pain
Time frame: Assessed within 30 days of study inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Derived from this study: PubMed 39540300Hauge MG, Damm P, Kofoed KF, Moller ELR, Lopez AG, Ersboll AS, Johansen M, Sigvardsen PE, Pham MHC, Goetze JP, Fuchs A, Kuhl JT, Nordestgaard BG, Kober LV, Gustafsson F, Linde JJ. Left Ventricular Hypertrophy in Women With a History of Preeclampsia. Hypertension. 2025 May;82(5):774-783. doi: 10.1161/HYPERTENSIONAHA.124.23497. Epub 2024 Nov 14.
- Derived from this study: PubMed 38588914Hauge MG, Linde JJ, Kofoed KF, Ersboll AS, Johansen M, Sigvardsen PE, Fuchs A, Mikkelsen AP, Gustafsson F, Damm P. Early-onset vs late-onset preeclampsia and risk of coronary atherosclerosis later in life: a clinical follow-up study. Am J Obstet Gynecol MFM. 2024 May;6(5):101371. doi: 10.1016/j.ajogmf.2024.101371. Epub 2024 Apr 6.
- Derived from this study: PubMed 35680182Hauge 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.
- Individual participant dataSharing planned: Undecided. Logistics and patient data protection issues will be explored prior to decision on IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Damm, MD, DmSc study chair
Department of Obstetrics, Rigshospitalet, University of Copenhagen, Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia and Atherosclerosis, run by Klaus Fuglsang Kofoed at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary atherosclerosis (time frame: Assessed within 30 days of study inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949829, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.