← Back to Search

ARTSENS Pen for High Blood Pressure in Pregnancy (ARTSEN Trial)

N/A
Waitlist Available
Led By Indu Poornima, MD
Research Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

ARTSEN Trial Summary

This trial will help researchers understand how high blood pressure in pregnancy may affect the heart and cardiovascular system.

Who is the study for?
This trial is for adult women over 18 who developed high blood pressure during a single pregnancy, without prior hypertension. They must be able to visit West Penn Hospital post-partum at specific times and read and understand English to give consent.Check my eligibility
What is being tested?
The study uses the ARTSENS Pen to monitor heart and cardiovascular system changes in women with pregnancy-related hypertensive disorders like pre-eclampsia or eclampsia.See study design
What are the potential side effects?
Since the ARTSENS Pen is a diagnostic tool rather than a medication, it's not expected to have side effects like drugs do. It's used for monitoring health conditions.

ARTSEN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Diastolic function
Change in Systolic Function measured as Left ventricular ejection fraction (LVEF)
Change in vascular compliance
+1 more
Secondary outcome measures
Troponin
Correlation of vascular compliance and stiffness

ARTSEN Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Pregnant with gestational hypertensionExperimental Treatment1 Intervention
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.
Group II: Pregnant with Pre-eclampsiaExperimental Treatment1 Intervention
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.
Group III: Pregnant without Hypertension - ControlActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor
47 Previous Clinical Trials
13,067 Total Patients Enrolled
Indu Poornima, MDPrincipal InvestigatorAllegheny Health Network Research Insititute

Media Library

ARTSENS Pen Clinical Trial Eligibility Overview. Trial Name: NCT04713228 — N/A
Pre-eclampsia Research Study Groups: Pregnant with Pre-eclampsia, Pregnant with gestational hypertension, Pregnant without Hypertension - Control
Pre-eclampsia Clinical Trial 2023: ARTSENS Pen Highlights & Side Effects. Trial Name: NCT04713228 — N/A
ARTSENS Pen 2023 Treatment Timeline for Medical Study. Trial Name: NCT04713228 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment of this research project?

"Absolutely. As per the information hosted on clinicaltrials.gov, this medical trial is still in its recruitment phase – it was first posted on July 1st 2021 and last modified August 21st 2022. The study requires 50 participants to be sourced from two separate locations."

Answered by AI

Are there any participants being sought for this clinical experiment?

"Clinicaltrials.gov confirms that this trial is recruiting participants; it was published on July 1st 2021 and last revised around the 21st of August 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Prospective Case-Control Study of Cardiovascular Changes in Pregnancy Related Hypertensive Disorders
Indu Poornima 2021. "Prospective Case-Control Study of Cardiovascular Changes in Pregnancy Related Hypertensive Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04713228.
~3 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top