Efficacy of Ambulatory Intravenous Diuresis for Chronic Heart Failure Patients: Insights from the DEA-HF Trial

Figures

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  Figure 1. Trial design and patient population. (A) Trial flow diagram, describing the sequential treatment design, the total number of enrolled patients and the timing of dropout cases. Initial assessment for baseline characteristics was performed on Week 1 before administration of the first treatment. Final follow‐up assessment was performed on Weeks 4 and 8. (B) Summary table of the administered treatments, as a result of treatment sequence randomization and patient dropout. (C) Summary pie chart of baseline treatment in the day‐care HF unit. New patients were defined as patients with a single visit (or less) in the 90 days prior to randomization. All other patients were considered as recurrent patients. Mean ± SD are presented.

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  Figure 2. Efficacy of weekly high‐intensity diuretic treatments. (A,B) The three diuretic regimens in the trial (furosemide alone, furosemide plus metolazone and furosemide plus acetazolamide) were administered in a random sequence and pooled according to their chronological order (i.e., administered on Visit 1, 2 or 3). The efficacy of the treatment was measured as total excreted sodium weight (A) and urine volume (B) 6 h after treatment initiation. Model estimates of mean and 95% confidence interval are presented. No statistically significant differences were detected.

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  Figure 3. Outcomes of three consecutive high‐intensity diuretic treatments. (A–C) Statistical analysis of pre‐ and post‐trial measurements, marked as ‘baseline’ and ‘Week 4’, respectively. Serum N‐terminal‐pro‐brain natriuretic peptide (A), body weight (B) and B‐line count (acquired using lung ultrasound at six sites, C) are presented as model estimates and 95% confidence interval. *P < 0.05, ** P < 0.01, *** P < 0.001. (D) Pre‐ and post‐trial calculated congestion score, ranging from 0 to 10, where higher mark indicates more pronounced congestion. The score is a sum of individual sub‐scores of ascites, pleural effusion and pedal oedema. Median and interquartile range are presented. P = 0.037 in an ordered logistic regression.

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  Figure 4. Short term effects of high‐intensity diuresis on vital signs. (A–C) Vital signs were measured immediately before administration of diuretic treatment and 6 h after its initiation (i.e., 2 h after treatment cessation). Vital signs included systolic blood pressure (A), diastolic blood pressure (B) and heart rate (C). Statistical analysis was performed individually for each study visit without correction for multiple comparisons. Model estimates of mean and 95% confidence interval are presented.

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  Figure 5. Statistical analysis of safety‐related laboratory measurements. (A–C) Pre‐ and post‐trial measurements were analysed to detect statistically significant differences in serum creatinine (A), blood sodium (B) and blood potassium (C). Model estimates of mean and 95% confidence interval are presented. ***P < 0.001. Correction for multiple pairwise comparisons was performed using post‐hoc Bonferroni test.