PreeclampsiaNCT05277233
Cardiovascular Risk After Preeclampsia
An observational study of Preeclampsia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Investigation of cardiovascular risk 5-15 years after early or late-onset preeclampsia by adenosine stress Magnetic Resonance Imaging and non-invasive methods like retinal vessel analysis, skin measurement of advanced glycation end products, flow-mediated dilation or pulse wave analysis in comparison to women after… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 4 Apr 2022to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Woman 5-15 years after pregnancy
Who may be able to join
- Women
- 18-60 years
- 5-15 years postpartum
Who cannot join
- Atrioventricular block, chronic obstructive pulmonary disease, bronchial asthma
- Pregnancy and/or active breastfeeding
- Glaucoma disease, epilepsy
- In addition for MRI: metal implants, electric devices, intolerance of contrast media, claustrophobia, renal or hepatic dysfunction (GFR < 30 ml/min)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Experimental and Clinical Research Center
Berlin, 13125
Anja Mähler, PhD, +49 30 450540 323, anja.maehler@charite.de
Kristin Kräker, PhD, +49 30 450540 328, kristin.kraeker@charite.de
About this study
Official title: Endothelial Dysfunction and Cardiovascular Risk After Preeclampsia
Investigation of cardiovascular risk 5-15 years after early or late-onset preeclampsia by adenosine stress Magnetic Resonance Imaging and non-invasive methods like retinal vessel analysis, skin measurement of advanced glycation end products, flow-mediated dilation or pulse wave analysis in comparison to women after healthy pregnancies.
- Conditions
- Preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early-onset preeclampsia | Defined as preeclampsia that develops before 34 weeks of gestation | |
| Late-onset preeclampsia | Defined as preeclampsia that develops after 34 weeks of gestation | |
| Control | Healthy pregnancies, matched to early and late-onset cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial perfusion
Measured by adenosine stress Magnetic Resonance Imaging (ml/min/g)
Measured: Day 2
Secondary outcomes (18)
Cardiac fibrosis
Measured by Magnetic Resonance Imaging (g)
Measured: Day 2
Immune cell phenotypes
Measured in isolated peripheral blood mononuclear cells
Measured: Day 1
Concentration of N-terminal prohormone of brain natriuretic peptide
Measured in serum (ng/l)
Measured: Day 1
Concentration of brain natriuretic peptide
Measured in serum (ng/l)
Measured: Day 1
Urinary protein
Measured in spot urine (mg)
Measured: Day 1
Advanced glycation end products
Measured by skin autofluorescence (arbitrary units)
Measured: Day 1
Body fat mass
Measured by bioimpedance analysis (%)
Measured: Day 1
Body fat-free mass
Measured by bioimpedance analysis (%)
Measured: Day 1
Hand grip strength
Measured by dynamometer (kg)
Measured: Day 1
Systolic blood pressure
Mean of three consecutive blood pressure measurements (mmHg)
Measured: Day 1
Diastolic blood pressure
Mean of three consecutive blood pressure measurements (mmHg)
Measured: Day 1
Pulse wave velocity
Calculated by algorithm based on age and blood pressure values (m/s)
Measured: Day 1
Flow-mediated dilation
Measured by brachial artery diameter (µm)
Measured: Day 1
Reactive hyperemia index
Measured by finger plethysmography
Measured: Day 1
Choroidal thickness
Measured with Optical Coherence Tomography (µm)
Measured: Day 1
Macular volume
Measured with Optical Coherence Tomography (mm³)
Measured: Day 1
Arterial dilation induced by retinal flicker stimulation
Measured with Dynamic Vessel Analyser (seconds)
Measured: Day 1
Venous dilation induced by retinal flicker stimulation
Measured with Dynamic Vessel Analyser (seconds)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start4 Apr 2022
- Primary completionApr 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Kraeker, Charite University, Berlin, Germany
- Investigators
- Anja Mähler, PhD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277233
- Sponsor's protocol ID
- CARPE
- Status last verified
- Jul 2024
- First submitted
- 18 Feb 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction and Cardiovascular Risk After Preeclampsia
- ClinicalTrials.gov ID
- NCT05277233
- Acronym / sponsor ID
- CARPE
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 14 Mar 2022 (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.
Investigation of cardiovascular risk 5-15 years after early or late-onset preeclampsia by adenosine stress Magnetic Resonance Imaging and non-invasive methods like retinal vessel analysis, skin measurement of advanced glycation end products, flow-mediated dilation or pulse wave analysis in comparison to women after healthy pregnancies.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early-onset preeclampsia | – | –Defined as preeclampsia that develops before 34 weeks of gestation |
| Late-onset preeclampsia | – | –Defined as preeclampsia that develops after 34 weeks of gestation |
| Control | – | –Healthy pregnancies, matched to early and late-onset cases |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Woman 5-15 years after pregnancy
Key inclusion criteria (3 listed)
- Women
- 18-60 years
- 5-15 years postpartum
Key exclusion criteria (4 listed)
- Atrioventricular block, chronic obstructive pulmonary disease, bronchial asthma
- Pregnancy and/or active breastfeeding
- Glaucoma disease, epilepsy
- In addition for MRI: metal implants, electric devices, intolerance of contrast media, claustrophobia, renal or hepatic dysfunction (GFR < 30 ml/min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myocardial perfusion
Time frame: Day 2
Measured by adenosine stress Magnetic Resonance Imaging (ml/min/g)
18 secondary outcomes
Cardiac fibrosis
Time frame: Day 2
Immune cell phenotypes
Time frame: Day 1
Concentration of N-terminal prohormone of brain natriuretic peptide
Time frame: Day 1
Concentration of brain natriuretic peptide
Time frame: Day 1
Urinary protein
Time frame: Day 1
Advanced glycation end products
Time frame: Day 1
Body fat mass
Time frame: Day 1
Body fat-free mass
Time frame: Day 1
Hand grip strength
Time frame: Day 1
Systolic blood pressure
Time frame: Day 1
Diastolic blood pressure
Time frame: Day 1
Pulse wave velocity
Time frame: Day 1
Flow-mediated dilation
Time frame: Day 1
Reactive hyperemia index
Time frame: Day 1
Choroidal thickness
Time frame: Day 1
Macular volume
Time frame: Day 1
Arterial dilation induced by retinal flicker stimulation
Time frame: Day 1
Venous dilation induced by retinal flicker stimulation
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
Related trials for Preeclampsia
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Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
Preeclampsia Postpartum
Active, not recruitingEarly Phase 1
Daily Aspirin Treatment After Preeclampsia
Preeclampsia
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
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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.
Anja Mähler, PhD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Charite University, Berlin, Germany at 1 site in Germany.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristin Kräker, PhD (+49 30 450540 328, kristin.kraeker@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial perfusion (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2024.