Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-30 @ 8:43 PM
Study NCT ID:
NCT06523569
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2024-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mHEART
Brief Summary:
The purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (HDP).
Detailed Description:
The purpose of this research is to test the effect of two digital health interventions on cardiovascular health and subclinical cardiac dysfunction in postpartum individuals after pregnancies complicated by new-onset hypertensive disorder of pregnancy (HDP). All participants will undergo echocardiography and have their blood pressure/weight captured at 3 months and 12 months postpartum. If randomized to the intervention arm, the participant will be given a subscription to a mobile health application and a digital blood pressure monitoring system, and asked to utilize these at home during the one year of the study along with usual care. If randomized to the control arm, the participant will receive care as usual.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: