PreeclampsiaPPC1NCT03313063
Post-Pregnancy Cardio Trial
An observational study of Preeclampsia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Preeclampsia is a systemic pregnancy disorder and is associated with an increased cardiovascular risk later in life. This study will characterize myocardial tissue in patients after preeclampsia compared to controls and investigate potential functional and structural changes in the heart of preeclamptic women… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- How many people
- 47 participants
- Where
- 1 siteGermany
- Study dates
- 28 Aug 2017to 30 Jun 2018
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women between 18 and 50 years of age, 0.5 - 20 years postpartum either with preeclampsia diagnosis during index pregnancy or without pathological findings. Controls are matched to cases based on age and BMI.
Who may be able to join
- postpartal window: 0.5 - 20 years
- cases: diagnosis of preeclampsia during the index pregnancy
- controls: age and BMI matched
Who cannot join
- metal implants
- kidney insufficiency (GFR < 30 ml/min/)
- claustrophobia
- contrast medium allergy
- current pregnancy/ lactation
- chronic hypertension (> 140/90)
Show all 9Show fewer
- diagnosis of previous cardiovascular disease
- body weight over 120 kg
- big tattoos in thorax area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myocardial Characterization With Magnetic Resonance Imaging in Patients After Preeclampsia (Pilot Study)
Preeclampsia is a systemic pregnancy disorder and is associated with an increased cardiovascular risk later in life. This study will characterize myocardial tissue in patients after preeclampsia compared to controls and investigate potential functional and structural changes in the heart of preeclamptic women primarily with two methods: cardiovascular magnetic resonance imaging and echocardiography. A comparison between these two methods, where appropriate, is also envisaged.
- Conditions
- Preeclampsia
- Keywords
- magnetic resonance imaging, myocard, 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 |
|---|---|---|
| PE | Women with a history or preeclampsia, between 18 - 50 years of age, 0.5 - 20 years postpartum | |
| Control | Age-matched women without any birth complications, between 18 - 50 years of age, 0.5 - 20 years postpartum |
What is being measured
The primary outcome is the main question the study is designed to answer.
any structural or functional change of the heart (combined outcome)
Combined outcome: myocardial fibrosis, edema, fat infiltrates, inflammation, reduced ejection fraction, hypertrophy
Measured: 0.5 - 20 years after delivery
Secondary outcomes (6)
myocardial fibrosis
Measured: 0.5 - 20 years after delivery
myocardial edema
Measured: 0.5 - 20 years after delivery
myocardial fat infiltrates
Measured: 0.5 - 20 years after delivery
myocardial inflammation
Measured: 0.5 - 20 years after delivery
myocardial hypertrophy
Measured: 0.5 - 20 years after delivery
reduced ejection fraction
Measured: 0.5 - 20 years after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start28 Aug 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
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
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian Herse, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313063
- Sponsor's protocol ID
- PPC1
- Acronym
- PPC1
- Status last verified
- Jul 2018
- First submitted
- 13 Oct 2017
- Last updated
- 26 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Characterization With Magnetic Resonance Imaging in Patients After Preeclampsia (Pilot Study)
- ClinicalTrials.gov ID
- NCT03313063
- Acronym / sponsor ID
- PPC1 / PPC1
- Conditions
- Preeclampsia
- Keywords
- magnetic resonance imaging, myocard, preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 18 Oct 2017 (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.
Preeclampsia is a systemic pregnancy disorder and is associated with an increased cardiovascular risk later in life. This study will characterize myocardial tissue in patients after preeclampsia compared to controls and investigate potential functional and structural changes in the heart of preeclamptic women primarily with two methods: cardiovascular magnetic resonance imaging and echocardiography. A comparison between these two methods, where appropriate, is also envisaged.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PE | – | –Women with a history or preeclampsia, between 18 - 50 years of age, 0.5 - 20 years postpartum |
| Control | – | –Age-matched women without any birth complications, between 18 - 50 years of age, 0.5 - 20 years postpartum |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women between 18 and 50 years of age, 0.5 - 20 years postpartum either with preeclampsia diagnosis during index pregnancy or without pathological findings. Controls are matched to cases based on age and BMI.
Key inclusion criteria (3 listed)
- postpartal window: 0.5 - 20 years
- cases: diagnosis of preeclampsia during the index pregnancy
- controls: age and BMI matched
Key exclusion criteria (9 listed)
- metal implants
- kidney insufficiency (GFR < 30 ml/min/)
- claustrophobia
- contrast medium allergy
- current pregnancy/ lactation
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
any structural or functional change of the heart (combined outcome)
Time frame: 0.5 - 20 years after delivery
Combined outcome: myocardial fibrosis, edema, fat infiltrates, inflammation, reduced ejection fraction, hypertrophy
6 secondary outcomes
myocardial fibrosis
Time frame: 0.5 - 20 years after delivery
myocardial edema
Time frame: 0.5 - 20 years after delivery
myocardial fat infiltrates
Time frame: 0.5 - 20 years after delivery
myocardial inflammation
Time frame: 0.5 - 20 years after delivery
myocardial hypertrophy
Time frame: 0.5 - 20 years after delivery
reduced ejection fraction
Time frame: 0.5 - 20 years after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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Preeclampsia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 9 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: finished, as of the sponsor's last update on 26 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
any structural or functional change of the heart (combined outcome) (time frame: 0.5 - 20 years after delivery). 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 26 Jul 2018.