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临床试验/NCT05528588
NCT05528588已完成2 期

Efficacy of Furoscix in Heart Failure Patients With Diuretic Resistance

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年6月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
70
试验地点
1
主要终点
Post-treatment Urine Output as Measured by Cumulative Urine Output Within 1 Day.

研究概览

简要总结

This will be a randomized, open-label pilot study of 70 patients with and without diuretic resistance who were recently admitted and discharged for acute decompensated heart failure with and oral diuretic regimen testing whether Furoscix is more effective at achieving post-discharge outpatient diuresis than standard of care. Diuretic resistance will be identified using the BAN-ADHF (BUN, creAtinine, NP-levels, Age, Diabetes and DBP, HF hospitalization, and atrial Fibrillation) score which has been integrated into the electronic health record. The score is integer-based with a score of ≥ 12 indicating diuretic resistance with high likelihood of poor outcomes. The primary outcome is diuretic efficacy as measured by volume of urine produced 8 hours after treatment and urine sodium levels (assessed hourly or per urination episode within 8 hours of treatment).

详细描述

Heart failure is one of the leading causes of hospitalization in the United States, contributing to over 1 million emergency department visits and nearly 1 million hospitalizations for HF annually. The estimated mean cost for HF was $11,552 in 2014, totaling an estimated $11 billion. Thus, strategies to reduce the burden of acute care use for patients with heart failure are necessary. Acute decompensation of heart failure is characterized by volume overload and is primarily treated with intravenous diuretics. However, inefficient and ineffective diuresis both during hospitalization and in the post-discharge environment predispose patients to frequent readmission and a worse prognosis. Importantly, there is heterogeneity in patient response to intravenous diuresis, with an estimated 20-50% of patients having poor response to initial IV diuretic therapy. Patients who are resistant to intravenous diuresis have increased risk of rehospitalization and mortality. Importantly, our group recently derived an integer-based risk score (BAN-ADHF score) to predict patients with low diuretic efficiency.

The investigators will screen eligible patients in the inpatient setting and schedule a research appointment within 14 days after discharge. At the research appointment, patients will be consented and undergo stratified randomization based on BAN-ADHF score (≥ 12 vs. <=11). Within each stratum, patients will be randomized in a 1:1 ratio (intervention: control). The intervention arm (Furoscix over 5 hours at 8mg/mL) will be compared to a usual care group (home oral diuretic dose prescribed by discharge physician). Patients will be monitored for 8 hours in the Clinical Research Unit post-drug administration for clinical safety and to measure clinical response. This study will take place at the Clinical Research Unit in the Aston Building at UT Southwestern Medical Center.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English-speaking patients discharged after ward hospitalization for acute decompensated heart failure
  • Able to be screened and enrolled within 14 days of hospitalization
  • Recent echocardiogram (6 months or less)
  • Discharged with home diuretic regimen

排除标准

  • Chronic kidney disease stage 5 (eGFR<20) or End Stage Kidney Disease
  • Systolic blood pressure <100
  • ICU hospitalization within 3 months
  • Inotrope use within last 3 months
  • Home inotropes
  • Electrolyte abnormalities on discharge
  • Inadequate data for BAN-ADHF score
  • Prior heart transplantation or left ventricular assist device
  • Low-output heart failure
  • Concurrent use of non-loop diuretic
  • Advanced liver disease
  • Severe malnutrition
  • Skin/Soft tissue condition precluding Furoscix
  • Inability to collect urine

研究组 & 干预措施

≥ 12 BAN-ADHF, Furoscix

Experimental

Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive Furoscix over 5 hours at 8 mg/mL.

干预措施: Furoscix (Combination Product)

<= 11 BAN-ADHF, Furoscix

Experimental

Patients without diuretic resistance as determined by BAN-ADHF score <= 11 will receive Furoscix over 5 hours at 8 mg/mL.

干预措施: Furoscix (Combination Product)

≥ 12 BAN-ADHF, control

Active Comparator

Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive home dose oral diuretic.

干预措施: Diuretic Therapy (Drug)

<= 11 BAN-ADHF, control

Active Comparator

Patients without diuretic resistance as determined by BAN-ADHF score <= 11 will receive home dose oral diuretic

干预措施: Diuretic Therapy (Drug)

结局指标

主要结局

Post-treatment Urine Output as Measured by Cumulative Urine Output Within 1 Day.

时间窗: 1 day

Post-treatment diuretic efficiency is measured by cumulative urine output in mL per mg of treatment, observed hourly through 8 hours following the administration of study therapy (Furoscix vs. oral furosemide).

次要结局

  • Post-treatment Peak Spot Urine Sodium Levels in 1 Day(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ambarish Pandey

ASSISTANT PROFESSOR - Internal Medicine (Cardiology)

University of Texas Southwestern Medical Center

研究点 (1)

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