CLOROTIC
Trial question
What is the effect of hydrochlorothiazide addition to loop diuretic therapy in patients with acute HF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
48.0% female
52.0% male
N = 230
230 patients (111 female, 119 male).
Inclusion criteria: hospitalized adult patients with acute decompensated HF.
Key exclusion criteria: unstable on admission; treatment with inotropic agents; or any thiazide
diuretic during the month before admission.
Interventions
N=114 hydrochlorothiazide (at a dose of 25-100 mg/day, adjusted according to GFR, plus intravenous furosemide regimen).
N=116 placebo (matching placebo plus intravenous furosemide regimen).
Primary outcome
Reduction in weight at 72 hours
2.3 kg
1.5 kg
2.3 kg
1.7 kg
1.1 kg
0.6 kg
0.0 kg
Hydrochlorothiazide
Placebo
Significant
increase ▲
Significantly greater reduction in weight at 72 hours (2.3 kg vs. 1.5 kg; AD 1.14 kg, 95% CI 0.42 to 1.84).
Secondary outcomes
No significant difference in patient-reported dyspnea using area under curve for the VAS at 72 hours (960 vs. 720; AD 240 , 95% CI -436.98 to 916.98).
Significant increase in weight reduction at 96 hours (2.5 kg vs. 1.5 kg; AD 1.57 kg, 95% CI 0.76 to 2.35).
No significant difference in patient-reported dyspnea using area under curve for the VAS at 96 hours (1500 vs. 1320; AD 180 , 95% CI -389.96 to 749.96).
Safety outcomes
No significant difference in reduction in eGFR > 50%.
Significant differences in impaired renal function (46.5% vs. 17.2%), elevation in creatinine > 26.5 umol/L (46.5% vs. 17.2%).
Conclusion
In hospitalized adult patients with acute decompensated HF, hydrochlorothiazide was superior to placebo with respect to reduction in weight at 72 hours.
Reference
Joan Carles Trullàs, José Luis Morales-Rull, Jesús Casado et al. Combining loop with thiazide diuretics for decompensated heart failure: the CLOROTIC trial. Eur Heart J. 2023 Feb 1;44(5):411-421.
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