Pre-Eclampsia Clinical Trial
— ARTSENOfficial title:
Prospective Case-Control Study of Cardiovascular Changes in Pregnancy Related Hypertensive Disorders
NCT number | NCT04713228 |
Other study ID # | 2019-128 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | January 17, 2024 |
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.
Status | Terminated |
Enrollment | 12 |
Est. completion date | January 17, 2024 |
Est. primary completion date | January 17, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Case Inclusion Criteria: 1. Adult females age > 18 years 2. Must be able to read and understand English and consent for themselves 3. Must have a singleton pregnancy and a diagnosis of preeclampsia or gestational hypertension 4. 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: 1. Prior history of hypertension 2. Multiple pregnancies 3. 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. 4. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. Control Inclusion Criteria: 1. Adult females age > 18 years 2. Must be able to read and understand English and consent for themselves 3. Must have a singleton pregnancy and not have a prior or current diagnosis of hypertension 4. Must be willing and able to come to West Penn Hospital for post-partum visits at 6-8 weeks. Control Exclusion Criteria: 1. Prior history and/or current diagnosis of hypertension 2. Multiple pregnancies 3. 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. 4. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. |
Country | Name | City | State |
---|---|---|---|
United States | West Penn Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
6 months | |
Primary | Change in Diastolic function | Measurement: E/E' velocity; This is a ratio and there is no unit for measurement.
Measurement tools: Pulse Doppler echocardiography |
6 months | |
Primary | 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 |
6 months | |
Primary | Change in vascular stiffness | Measurement: Beta which is an index without units
Measurement tool: Arterial waveforms captured with the ARTSENS device |
6 months | |
Secondary | 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. |
3 months | |
Secondary | 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. |
3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03299777 -
Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan
|
N/A | |
Completed |
NCT03650790 -
C1q/TNF-related Protein 9 (CTRP 9) Level in Preeclamptic Obese and Non-obese Pregnancies
|
N/A | |
Recruiting |
NCT03605511 -
TTP and aHUS in Complicated Pregnancies
|
||
Not yet recruiting |
NCT03302260 -
Identifying Methods for Postpartum Reduction of Vascular Events: Pilot Randomized Controlled Trial
|
N/A | |
Completed |
NCT02911701 -
Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features
|
Phase 4 | |
Completed |
NCT01911494 -
Community Level Interventions for Pre-eclampsia
|
N/A | |
Terminated |
NCT02025426 -
Phenylephrine Versus Ephedrine in Pre-eclampsia
|
Phase 4 | |
Completed |
NCT01352234 -
Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia
|
Phase 4 | |
Active, not recruiting |
NCT02031393 -
Establishing First Trimester Markers for the Identification of High Risk Twin
|
N/A | |
Terminated |
NCT00141310 -
Sildenafil Citrate for the Treatment of Established Pre-Eclampsia
|
Phase 2 | |
Completed |
NCT00157521 -
L-Arginine in Pre-Eclampsia
|
Phase 3 | |
Completed |
NCT04795154 -
Prenatal Yoga as Complementary Therapy of Preeclampsia
|
N/A | |
Completed |
NCT00004399 -
Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia
|
N/A | |
Completed |
NCT00005207 -
Renin and Prorenin in Pregnancy
|
N/A | |
Recruiting |
NCT04551807 -
Natural Versus Programmed Frozen Embryo Transfer (NatPro)
|
Phase 3 | |
Terminated |
NCT04092829 -
Impact of Corpus Luteum Presence or Absence in the Incidence of Preeclampsia After Frozen Embryo Transfer
|
N/A | |
Recruiting |
NCT06067906 -
Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients
|
N/A | |
Recruiting |
NCT06317467 -
Role of Anti-C1q Autoantibodies in Pregnancy
|
||
Completed |
NCT02218931 -
ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes
|
N/A | |
Active, not recruiting |
NCT04484766 -
Preeclampsia Associated Vascular Aging
|