Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593327
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
NT-ProBNP-based Heart Failure Screening and Prevention Trial in Patients With Type 2 Diabetes STRONG-DM Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of a Pragmatic NT-ProBNP-based Heart Failure Screening Strategy Among Patients With Type 2 Diabetes STRONG-DM Study Screening and Treatment Using Risk-based apprOach With NT-ProBNP Guidance in Diabetes Mellitus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRONG-DM
Brief Summary:
A pragmatic randomized clinical trial to evaluate the effect of a heart failure HF risk assessment and prevention strategy incorporating HF clinical risk scores WATCH-DM with cardiac biomarker NT-proBNP paired with a clinical decision support tool to implement an intensive prevention strategy among patients with high risk focused on implementation of evidence-based HF preventive therapies
Detailed Description:
Primary care providers will be randomized to receive notifications via the electronic health record if any patients with diabetes have high heart failure risk based on a combination of clinical risk scoresWATCH-DM and biomarkers NT-proBNP Providers will be provided recommendation to initiate evidence based therapies SGLT2 inhibitors GLP1 agonists non-steroidal MRA obtain expert e-consultation or refer the patient to a cardiometabolic risk management program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None