Pre-EclampsiaARTSENNCT04713228
Prospective Case-Control Study of Cardiovascular Changes in Pregnancy Related Hypertensive Disorders
A study testing ARTSENS Pen in people with Pre-Eclampsia, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial summary
This is a research study to understand the changes in the heart and the cardiovascular system that may occur in women who develop high blood pressure during pregnancy. 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
- Pre-Eclampsia
- What is being tested?
- ARTSENS Pen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 17 Jan 2024
- Phase
- Interventional
- 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
Case Inclusion Criteria:
- Adult females age > 18 years
- Must be able to read and understand English and consent for themselves
- Must have a singleton pregnancy and a diagnosis of preeclampsia or gestational hypertension
- Must be willing and able to come to West Penn Hospital for post-partum visits at 6-8 weeks and then at 6-7 months.
Case Exclusion Criteria:
- Prior history of hypertension
- Multiple pregnancies
- Other comorbidities such as congenital heart disease, dialysis dependent renal failure, heroin abuse, cocaine abuse, pulmonary hypertension, congestive heart failure, autoimmune conditions such as SLE or severe lung disease.
- Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Control Inclusion Criteria:
- Adult females age > 18 years
- Must be able to read and understand English and consent for themselves
- Must have a singleton pregnancy and not have a prior or current diagnosis of hypertension
- Must be willing and able to come to West Penn Hospital for post-partum visits at 6-8 weeks.
Control Exclusion Criteria:
- Prior history and/or current diagnosis of hypertension
- Multiple pregnancies
- Other comorbidities such as congenital heart disease, dialysis dependent renal failure, heroin abuse, cocaine abuse, pulmonary hypertension, congestive heart failure, autoimmune conditions such as SLE or severe lung disease.
- Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Trial locations and contacts
1 site in 1 country.
About this study
This is a research study to understand the changes in the heart and the cardiovascular system that may occur in women who develop high blood pressure during pregnancy.
Read the detailed description
Upon Enrollment in this study, participants will go through two scans along with some blood test and other assessments. The first scan is a sonogram of the heart called an echocardiogram, and another scan is done using the investigational ARTSENS device that will be used to measure stiffness of the walls in the arterial blood vessel for indications of inflammation damage. ARTSENS device is not approved for use in the United States. It is expected that we will enroll 50 people in this study. The entire study is expected to last 2 years. Participation will be for approximately 9 months.
- Conditions
- Pre-Eclampsia
- Being tested
- ARTSENS Pen
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTSENS PenDevice
ARTerial Stiffness Evaluation for Noninvasive Screening
| Study group | Role | What they receive |
|---|---|---|
| Pregnant with Pre-eclampsia | Experimental | There will be an initial 'Pregnancy' visit within 7-10 days of the screening visit, when the subject will undergo an echocardiogram, have the vascular compliance measurements and will have blood drawn for measurement of serum biomarkers. The second study visit will be the '6-8 weeks post-partum' visit when the echocardiogram and vascular compliance will be re-measured, along with assessment of vitals and medication history. The third study visit will be 6-7 months post partum where there is a collection of a clinical questionnaire, demographics, vitals, chart review, echocardiogram and vascular compliance will be re-measured. Receives: Device: ARTSENS Pen |
| Pregnant with gestational hypertension | Experimental | There will be an initial 'Pregnancy' visit within 7-10 days of the screening visit, when the subject will undergo an echocardiogram, have the vascular compliance measurements and will have blood drawn for measurement of serum biomarkers. The second study visit will be the '6-8 weeks post-partum' visit when the echocardiogram and vascular compliance will be re-measured, along with assessment of vitals and medication history. The third study visit will be 6-7 months post partum where there is a collection of a clinical questionnaire, demographics, vitals, chart review, echocardiogram and vascular compliance will be re-measured. Receives: Device: ARTSENS Pen |
| Pregnant without Hypertension - Control | Active comparator | There will be an initial 'Pregnancy' visit within 7-10 days of the screening visit, when the subject will undergo an echocardiogram, have the vascular compliance measurements and will have blood drawn for measurement of serum biomarkers. The second study visit will be the '6-8 weeks post-partum' visit when the echocardiogram and vascular compliance will be re-measured, along with assessment of vitals and medication history. The third study visit is not applicable to the control group. Receives: Device: ARTSENS Pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Function measured as Left ventricular ejection fraction (LVEF)
Measurement: LVEF is expressed as a % and Global longitudinal strain measurement also expressed as %.
Measurements tools: two dimensional echocardiography and strain imaging with speckle tracking echocardiography
Measured: 6 months
Change in Diastolic function
Measurement: E/E' velocity; This is a ratio and there is no unit for measurement.
Measurement tools: Pulse Doppler echocardiography
Measured: 6 months
Change in vascular compliance
Measurement:
Pulse strain elasticity (Ep) expressed as kPa, Arterial stiffness Beta which is an index without units.
Measurement tool: Arterial waveforms captured with the ARTSENS device
Measured: 6 months
Change in vascular stiffness
Measurement: Beta which is an index without units
Measurement tool: Arterial waveforms captured with the ARTSENS device
Measured: 6 months
Secondary outcomes (2)
Correlation of left ventricular ejection fraction (LVEF) with troponin and proBNP
Cardiac measurements: LVEF is in %, Troponin is ng/ml, proBNP is pmol/L
Measurement tool:
LVEF is measured with 2D echocardiography, proBNP and Troponin is measured by blood sample assessing biomarker alterations that could predict cardiovascular damage.
Measured: 3 months
Correlation of vascular compliance and stiffness
Measurement: Pulse strain elasticity (Ep) expressed as kPa, Arterial stiffness Beta which is an index without units, E/E' is a ratio
Measurement tool: Arterial waveforms captured with the ARTSENS device and Doppler Echo.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Jul 2021
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Indu Poornima, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Indu Poornima, MD, Principal investigator, Allegheny Health Network Research Insititute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713228
- Sponsor's protocol ID
- 2019-128
- Acronym
- ARTSEN
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2021
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Results will be published; patient identifiers will not be used in the research publications.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Case-Control Study of Cardiovascular Changes in Pregnancy Related Hypertensive Disorders
- ClinicalTrials.gov ID
- NCT04713228
- Acronym / sponsor ID
- ARTSEN / 2019-128
- Conditions
- Pre-Eclampsia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 19 Jan 2021 (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.
This is a research study to understand the changes in the heart and the cardiovascular system that may occur in women who develop high blood pressure during pregnancy.
Detailed description
Upon Enrollment in this study, participants will go through two scans along with some blood test and other assessments. The first scan is a sonogram of the heart called an echocardiogram, and another scan is done using the investigational ARTSENS device that will be used to measure stiffness of the walls in the arterial blood vessel for indications of inflammation damage. ARTSENS device is not approved for use in the United States. It is expected that we will enroll 50 people in this study. The entire study is expected to last 2 years. Participation will be for approximately 9 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant with Pre-eclampsia | Experimental | Device: ARTSENS PenThere will be an initial 'Pregnancy' visit within 7-10 days of the screening visit, when the subject will undergo an echocardiogram, have the vascular compliance measurements and will have blood drawn for measurement of serum biomarkers. The second study visit will be the '6-8 weeks post-partum' visit when the echocardiogram and vascular compliance will be re-measured, along with assessment of vitals and medication history. The third study visit will be 6-7 months post partum where there is a collection of a clinical questionnaire, demographics, vitals, chart review, echocardiogram and vascular compliance will be re-measured. |
| Pregnant with gestational hypertension | Experimental | Device: ARTSENS PenThere will be an initial 'Pregnancy' visit within 7-10 days of the screening visit, when the subject will undergo an echocardiogram, have the vascular compliance measurements and will have blood drawn for measurement of serum biomarkers. The second study visit will be the '6-8 weeks post-partum' visit when the echocardiogram and vascular compliance will be re-measured, along with assessment of vitals and medication history. The third study visit will be 6-7 months post partum where there is a collection of a clinical questionnaire, demographics, vitals, chart review, echocardiogram and vascular compliance will be re-measured. |
| Pregnant without Hypertension - Control | Active comparator | Device: ARTSENS PenThere will be an initial 'Pregnancy' visit within 7-10 days of the screening visit, when the subject will undergo an echocardiogram, have the vascular compliance measurements and will have blood drawn for measurement of serum biomarkers. The second study visit will be the '6-8 weeks post-partum' visit when the echocardiogram and vascular compliance will be re-measured, along with assessment of vitals and medication history. The third study visit is not applicable to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ARTSENS PenARTerial Stiffness Evaluation for Noninvasive Screening | Device | Pregnant with Pre-eclampsia, Pregnant with gestational hypertension, Pregnant without Hypertension - Control |
Primary outcome
Change in Systolic Function measured as Left ventricular ejection fraction (LVEF)
Time frame: 6 months
Measurement: LVEF is expressed as a % and Global longitudinal strain measurement also expressed as %. Measurements tools: two dimensional echocardiography and strain imaging with speckle tracking echocardiography
Change in Diastolic function
Time frame: 6 months
Measurement: E/E' velocity; This is a ratio and there is no unit for measurement. Measurement tools: Pulse Doppler echocardiography
Change in vascular compliance
Time frame: 6 months
Measurement: Pulse strain elasticity (Ep) expressed as kPa, Arterial stiffness Beta which is an index without units. Measurement tool: Arterial waveforms captured with the ARTSENS device
Change in vascular stiffness
Time frame: 6 months
Measurement: Beta which is an index without units Measurement tool: Arterial waveforms captured with the ARTSENS device
2 secondary outcomes
Correlation of left ventricular ejection fraction (LVEF) with troponin and proBNP
Time frame: 3 months
Correlation of vascular compliance and stiffness
Time frame: 3 months
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No. Results will be published; patient identifiers will not be used in the research publications.
Related trials for Pre-Eclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe 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.
Indu Poornima, MD principal investigator
Allegheny Health Network Research Insititute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARTSENS Pen in people with Pre-Eclampsia, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) 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?
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: stopped early, as of the sponsor's last update on 30 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 was stopped early (reason given: slow enrollment). Results are not available in the source record.
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?
Change in Systolic Function measured as Left ventricular ejection fraction (LVEF) (time frame: 6 months). The study lists 4 primary outcomes in all. 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 30 Jan 2024.