NCT04697485

Polydiuretic Therapy for Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus

Polydiuretic Therapy for Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus: A Pilot Trial

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Patients with HFpEF and diabetes mellitus will receive polydiuretic therapy consisting of bumetanide 0.5 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

Conditions

• HF - Heart Failure
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Bumetanide 0.5 mg, dapaglifozin 5 mg, eplerenone 25 mg	Low-Dose, Triple Polydiuretic Therapy (LDTPT) Treatment consists of: * Loop diuretic (bumetanide 0.5 mg) * Mineralocorticoid receptor antagonist (eplerenone 25 mg) * Sodium-glucose co-transporter 2 inhibitor (SGLT2i): Farxiga® (dapagliflozin) 5 mg

Timeline

• Start date: 2021-01-08
• Primary completion: 2022-01-01
• Completion: 2022-03-30
• First posted: 2021-01-06
• Last updated: 2022-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study