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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949829
Recruitment Status : Enrolling by invitation
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Klaus Fuglsang Kofoed, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment
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

  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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Cardiovascular Disease After Preeclampsia
Estimated Study Start Date : May 20, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis


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


Primary Outcome Measures :
  1. Coronary atherosclerosis [ Time Frame: Assessed within 30 days of study inclusion ]
    Presensence of coronary plaque as defined by Cardiac CT


Secondary Outcome Measures :
  1. Presence of left bundle branch block [ Time Frame: Assessed within 30 days of study inclusion ]
    Electrocardiographic abnormality

  2. Presence of atrial fibrillation [ Time Frame: Assessed within 30 days of study inclusion ]
    Electrocardiographic abnormality

  3. Presence of T-wave inversion [ Time Frame: Assessed within 30 days of study inclusion ]
    Electrocardiographic abnormality

  4. Presence of left ventricular hypertrophy [ Time Frame: Assessed within 30 days of study inclusion ]
    Electrocardiographic abnormality

  5. Arterial hypertension [ Time Frame: Assessed within 30 days of study inclusion ]
    Presence of elevated blood pressure

  6. Dyspnoe [ Time Frame: Assessed within 30 days of study inclusion ]
    New York Heart Association class

  7. Chest pain [ Time Frame: Assessed within 30 days of study inclusion ]
    Canadian Cardiovascular Society angina pectoris class


Other Outcome Measures:
  1. Major cardiovascular events [ Time Frame: Assessed 1 year after Cardiac CT imaging ]
    Composite endpoint of either death, myocardial infarction, heart failure or stroke


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949829


Locations
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Denmark
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, Denmark, 2100
Department of Obstetrics, Rigshospitalet
Copenhagen, Denmark, 2100
The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark
Herlev, Denmark, 2730
Sponsors and Collaborators
Klaus Fuglsang Kofoed
Herlev Hospital
Investigators
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Study Chair: Peter Damm, MD, DmSc Department of Obstetrics, Rigshospitalet, University of Copenhagen, Denmark

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Responsible Party: Klaus Fuglsang Kofoed, Clinical Associated Research Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03949829     History of Changes
Other Study ID Numbers: H-18065695
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Logistics and patient data protection issues will be explored prior to decision on IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klaus Fuglsang Kofoed, Rigshospitalet, Denmark:
Pre- eclampsia
Heart disease in women
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Heart Diseases
Atherosclerosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications