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

• ClinicalTrials.gov Identifier: NCT03949829
• Recruitment Status: Active, not recruiting
• First Posted: May 14, 2019
• Last Update Posted: May 18, 2021
• Sponsor: Klaus Fuglsang Kofoed
• Collaborator: Herlev Hospital
• Information provided by (Responsible Party): Klaus Fuglsang Kofoed, Rigshospitalet, Denmark

Study Description

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.

Study Design

• 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

Groups and Cohorts

Intervention Details:

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Chair: Peter Damm, MD, DmSc; Department of Obstetrics, Rigshospitalet, University of Copenhagen, Denmark

More Information

• Responsible Party: Klaus Fuglsang Kofoed, Clinical Associated Research Professor, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT03949829
• Other Study ID Numbers: H-18065695
• First Posted: May 14, 2019
• Last Update Posted: May 18, 2021
• Last Verified: May 2021

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

• 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:

Pre-Eclampsia; Eclampsia; Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications