Preeclampsia Severe or MildECHONCT04063397
Persistent Postpartum Cardiovascular Dysfunction in Patients With Preeclampsia
An observational study of Preeclampsia Severe or Mild and Cardiac Complication, run by Ohio State University at 1 site in United States.
Trial summary
The investigators plan to enroll women with PE prospectively to evaluate incremental cardiovascular risk in those who have PE with severe features. This study includes detailed echocardiographic evaluation at several time points. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia Severe or Mild, Cardiac Complication
- What is being tested?
- Echocardiogram and Blood draw
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2019to 14 Dec 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 40 patients with preeclampsia with or without severe features 20 control group patients with no hypertensive disorder of pregnancy
Who may be able to join
- Females older than 18 years of age
- Singleton pregnancy
- The patient is physically and mentally able to understand the informed consent and is willing to participate in this study
- Able to speak English
- Must meet one of the population categories, until each group has reached 20 subjects
Who cannot join
- Multiple gestation
- History of chronic hypertension or cardiac disease including but not limited to history of heart arrhythmias, congenital heart disease, and use of any cardiac medication (such as beta blockers, ACE inhibitors, calcium channel blockers) prior to pregnancy.
- History of medical problems that may contribute to cardiac dysfunction, including but not limited to chronic hypertension, poorly controlled hyperthyroidism and diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators plan to enroll women with PE prospectively to evaluate incremental cardiovascular risk in those who have PE with severe features. This study includes detailed echocardiographic evaluation at several time points. With the current proposal, the investigators aim to collect blood to evaluate several biomarkers to determine if there is a correlation with short and medium-term cardiovascular risk. This opens the door to earlier detection, treatment and improved cardiovascular outcomes.
Read the detailed description
Preeclampsia (PE) is a multi-system progressive disorder affecting up to 8% of pregnancies. Epidemiologic studies have shown a significant association between PE and future cardiovascular disease (CVD) in women. Despite recognition of this relationship, there are no good markers to help determine which women are at highest risk, in particular as this relates to long-term cardiovascular risk, the number one cause of mortality in U.S. born women. As such, the study of PE and cardiovascular outcomes, in particular to identify early markers for the development of late CVD, provide insight into critical opportunities for early treatment and modification of disease trajectory in women.
The investigators plan to enroll women with PE prospectively to evaluate incremental cardiovascular risk in those who have PE with severe features. This study includes detailed echocardiographic evaluation at several time points. With the current proposal, the investigators aim to collect blood to evaluate several biomarkers to determine if there is a correlation with short and medium-term cardiovascular risk. This opens the door to earlier detection, treatment and improved cardiovascular outcomes.
The investigators hypothesize that preeclampsia with severe features confers a much higher risk of cardiovascular impairment compared to milder form of preeclampsia and healthy controls. If the hypothesis proves correct, these findings may change clinical practice by warranting routine echocardiogram for these patients for early recognition, intervention and treatment of cardiac dysfunction.
- Conditions
- Preeclampsia Severe or Mild, Cardiac Complication
- Being tested
- Echocardiogram, Blood draw
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiogramDiagnostic test
Serial echocardiograms will be done on all patients pre-delivery, and at 3-6 months
Blood drawDiagnostic test
Serial blood draws at same time points as echocardiograms for biomarker levels
| Study group | Role | What they receive |
|---|---|---|
| Preeclampsia | 40 patients diagnosed with preeclampsia with or without severe features Receives: Diagnostic Test: Echocardiogram; Diagnostic Test: Blood draw | |
| Control | 20 Control group of patients without hypertensive disorders of pregnancy Receives: Diagnostic Test: Echocardiogram; Diagnostic Test: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac dysfunction
The following parameters will be measured to assess cardiac dysfunction:
- LV Size/function
- Biplane Method of Disks LVEF (a4C and 2C views for EDV and ESV)
- LV Fractional shortening- Septal thickness and PW thickness
- LV Strain- Basal longitudinal, Mid LV longitudinal, Apical LV longitudinal and Global LV longitudinal strain
- 3D LV EF
- Tei index
- Analysis of LV diastolic function- Mitral E wave, Mitral A wave, Mitral e', Mitral E/e', Mitral E/A and Mitral Decel time
- LA volume
- RA volume
- IVC size/compressibility with inspiration
- RV size/function
- RV length
- RV basal width
- RV FAC %
- TAPSE
- S'
- Tei index
- TR velocity
- RVSP
- TAPSE
- Longitudinal strain- Basal Longi, Basal longitudinal, Mid LV longitudinal, Apical LV longitudinal and Global LV longitudinal strain
- Basic valve assessment
Measured: From delivery up to 3-6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start19 Aug 2019
- Primary completion30 Jan 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia Severe or MildStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Principal investigator, Kara M Rood, MD, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063397
- Sponsor's protocol ID
- 2018H0312
- Acronym
- ECHO
- Status last verified
- Jan 2024
- First submitted
- 19 Aug 2019
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Postpartum Cardiovascular Dysfunction in Patients With Preeclampsia
- ClinicalTrials.gov ID
- NCT04063397
- Acronym / sponsor ID
- ECHO / 2018H0312
- Conditions
- Preeclampsia Severe or Mild, Cardiac Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 21 Aug 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.
The investigators plan to enroll women with PE prospectively to evaluate incremental cardiovascular risk in those who have PE with severe features. This study includes detailed echocardiographic evaluation at several time points. With the current proposal, the investigators aim to collect blood to evaluate several biomarkers to determine if there is a correlation with short and medium-term cardiovascular risk. This opens the door to earlier detection, treatment and improved cardiovascular outcomes.
Detailed description
Preeclampsia (PE) is a multi-system progressive disorder affecting up to 8% of pregnancies. Epidemiologic studies have shown a significant association between PE and future cardiovascular disease (CVD) in women. Despite recognition of this relationship, there are no good markers to help determine which women are at highest risk, in particular as this relates to long-term cardiovascular risk, the number one cause of mortality in U.S. born women. As such, the study of PE and cardiovascular outcomes, in particular to identify early markers for the development of late CVD, provide insight into critical opportunities for early treatment and modification of disease trajectory in women.
The investigators plan to enroll women with PE prospectively to evaluate incremental cardiovascular risk in those who have PE with severe features. This study includes detailed echocardiographic evaluation at several time points. With the current proposal, the investigators aim to collect blood to evaluate several biomarkers to determine if there is a correlation with short and medium-term cardiovascular risk. This opens the door to earlier detection, treatment and improved cardiovascular outcomes.
The investigators hypothesize that preeclampsia with severe features confers a much higher risk of cardiovascular impairment compared to milder form of preeclampsia and healthy controls. If the hypothesis proves correct, these findings may change clinical practice by warranting routine echocardiogram for these patients for early recognition, intervention and treatment of cardiac dysfunction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preeclampsia | – | Diagnostic Test: Echocardiogram, Diagnostic Test: Blood draw40 patients diagnosed with preeclampsia with or without severe features |
| Control | – | Diagnostic Test: Echocardiogram, Diagnostic Test: Blood draw20 Control group of patients without hypertensive disorders of pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40 patients with preeclampsia with or without severe features 20 control group patients with no hypertensive disorder of pregnancy
Key inclusion criteria (5 listed)
- Females older than 18 years of age
- Singleton pregnancy
- The patient is physically and mentally able to understand the informed consent and is willing to participate in this study
- Able to speak English
- Must meet one of the population categories, until each group has reached 20 subjects
Key exclusion criteria (3 listed)
- Multiple gestation
- History of chronic hypertension or cardiac disease including but not limited to history of heart arrhythmias, congenital heart disease, and use of any cardiac medication (such as beta blockers, ACE inhibitors, calcium channel blockers) prior to pregnancy.
- History of medical problems that may contribute to cardiac dysfunction, including but not limited to chronic hypertension, poorly controlled hyperthyroidism and diabetes mellitus.
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 |
|---|---|---|
| EchocardiogramSerial echocardiograms will be done on all patients pre-delivery, and at 3-6 months | Diagnostic test | Control, Preeclampsia |
| Blood drawSerial blood draws at same time points as echocardiograms for biomarker levels | Diagnostic test | Control, Preeclampsia |
Primary outcome
Cardiac dysfunction
Time frame: From delivery up to 3-6 months postpartum
The following parameters will be measured to assess cardiac dysfunction: 1. LV Size/function 1. Biplane Method of Disks LVEF (a4C and 2C views for EDV and ESV) 2. LV Fractional shortening- Septal thickness and PW thickness 3. LV Strain- Basal longitudinal, Mid LV longitudinal, Apical LV longitudinal and Global LV longitudinal strain 4. 3D LV EF 5. Tei index 6. Analysis of LV diastolic function- Mitral E wave, Mitral A wave, Mitral e', Mitral E/e', Mitral E/A and Mitral Decel time 2. LA volume 3. RA volume 4. IVC size/compressibility with inspiration 5. RV size/function 1. RV length 2. RV basal width 3. RV FAC % 4. TAPSE 5. S' 6. Tei index 7. TR velocity 8. RVSP 9. TAPSE 10. Longitudinal strain- Basal Longi, Basal longitudinal, Mid LV longitudinal, Apical LV longitudinal and Global LV longitudinal strain 6. Basic valve assessment
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 10 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Severe or Mild and Cardiac Complication, run by Ohio State University at 1 site in United States.
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 5 inclusion and 3 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 10 Jan 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 United States. 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?
Cardiac dysfunction (time frame: From delivery up to 3-6 months postpartum). 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 10 Jan 2024.