Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04697485
Status:
WITHDRAWN
Last Update Posted:
2022-05-10
First Post:
2020-12-07
Brief Title:
Polydiuretic Therapy for Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Polydiuretic Therapy for Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus A Pilot Trial
Status:
WITHDRAWN
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment and funding challenges
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center non-randomzied pilot study investigating a combination of targeted therapies as possible treatment for heart failure with preserved ejection fraction HFpEF
The study interviention is a Low-Dose Triple Polydiuretic Therapy LDTPT or polydiuretic including loop diuretic bumetanide mineralocorticoid receptor antagonist eplerenone and Sodium-glucose co-transporter 2 inhibitors SGLT2i therapy dapaglifozin
The study interviention is a Low-Dose Triple Polydiuretic Therapy LDTPT or polydiuretic including loop diuretic bumetanide mineralocorticoid receptor antagonist eplerenone and Sodium-glucose co-transporter 2 inhibitors SGLT2i therapy dapaglifozin
Detailed Description:
Patients with HFpEF and diabetes mellitus will receive polydiuretic therapy consisting of bumetanide 05 mg eplerenone 25 mg dapaglifozin 5 mg on top of background therapy These medicines are currently FDA approved and recommended by clinical practice guidelines for the treatment of HFpEF bumetanide eplerenone and diabetes mellitus dapaglifozin
This study is designed to evaluate if combination pharmacotherapies with synergistic or additive diuretic properties can improve adherence treatment efficacy and effectiveness with fewer side effects
This study is designed to evaluate if combination pharmacotherapies with synergistic or additive diuretic properties can improve adherence treatment efficacy and effectiveness with fewer side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None