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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
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.
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.
Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand
RECRUITINGUrine volume
Total urine volume after randomisation
Time frame: 72 hours
Urine volume
Total urine volume after randomization
Time frame: 24 and 48 hours
Body weight
Changes of patient's body weight
Time frame: 72 hours after randomisation
Length of hospital admission
Number of days that patients need to stay in the hospital
Time frame: During hospital admission period
Furosemide dose
Total dosage of intravenous furosemide
Time frame: 72 hours after randomisation
Levels of B-type atrial natriuretic peptide (BNP)
levels of pro-BNP
Time frame: 72 hours and 7 days after randomisation
Number of participants with adverse events
All adverse events during hospital admission
Time frame: During hospital admission
Dyspnea score assessed by visual analogue scale
The scale is between 0 and 100. The higher scale represents lower level of dyspnea
Time frame: At randomization, and 6, 12, 24, 48 and 72 hours after randomization
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