NCT04465123

Early Sequential Nephron Blockade in Acute Heart Failure Patients: A Randomised, Controlled Study

Furosemide With Early Sequential Nephron Blockade Versus Furosemide Alone in Acute Heart Failure Patients With Furosemide-guided Diuretic Resistance: A Double-blinded, Randomized, Placebo-controlled Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Chiang Mai University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to demonstrate the efficacy of sequential nephron blockade by adding hydrochlorothiazide or spironolactone on intravenous furosemide compared to intravenous furosemide alone in the treatments of volume overload in patients with acute heart failure who have diuretic resistance from furosemide stress test.

Detailed description

This study is a randomised, double-blinded, double-dummy, placebo-controlled study to demonstrate the efficacy of oral hydrochlorothiazide or spironolactone in combination with intravenous furosemide compared to intravenous furosemide in combination with placebo. Dosage of intravenous furosemide will be adjusted according to pre-defined protocol. The primary outcome is urine volume during 72 hours after randomisation.

Conditions

• Acute Heart Failure
• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	Spironolactone or hydrochlorothiazide	Patients will be received spironolactone or hydrochlorothiazide in combination with intravenous furosemide according to patients' serum potassium levels. If serum potassium levels ≤4 mEq/L, patients will be received spironolactone 100 mg every 12 hour for 72 hours. If serum potassium levels \>4 mEq/L, patients will be received hydrochlorothiazide 50 mg every 12 hour for 72 hours.
DRUG	Placebo	Patients will be received spironolactone placebo or hydrochlorothiazide placebo in combination with intravenous furosemide according to patients' serum potassium levels. If serum potassium levels ≤4 mEq/L, patients will be received spironolactone placebo every 12 hour for 72 hours. If serum potassium levels \>4 mEq/L, patients will be received hydrochlorothiazide placebo every 12 hour for 72 hours.

Timeline

• Start date: 2020-08-13
• Primary completion: 2022-07-31
• Completion: 2022-12-31
• First posted: 2020-07-09
• Last updated: 2020-08-18

Locations

1 site across 1 country: Thailand