Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)
不适用
已完成
NCT05174312
| 适应症 | Acute Decompensated Heart Failure |
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| 分期 | 不适用 |
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| 申办方 | Reprieve Cardiovascular, Inc |
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| 状态 | 已完成 |
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| 受试者人数 | 100 人 |
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| 干预(药物) | Reprieve Decongestion Management System, Diuretic |
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| 开始日期 | 2022年7月11日 |
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| 完成日期 | 2025年1月10日 |
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| 结果公布日 | 2026年5月29日 |
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摘要
The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve DMS can more efficiently decongest ADHF patients in comparison to Control Therapy.
Total Urine Sodium Output
24 hours post-treatment initiation · mmol of sodium
| Reprieve Decongestion Management System | 1082 ± 487 mmol of sodium |
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| Optimal Diuretic Therapy | 423 ± 290 mmol of sodium |
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Clinically Significant Acute Kidney Injury, Severe Electrolyte Abnormality, Symptomatic Hypotension or Hypertensive Emergency.
End of treatment, 0-72 hours. · total number of events
| Reprieve Decongestion Management System | 16 total number of events |
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| Optimal Diuretic Therapy | 19 total number of events |
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