Clinical trial NCT05528588: Furoscix in Heart Failure Patients With Diuretic Resistance
Official title: Efficacy of Furoscix in Heart Failure Patients With Diuretic Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: scPharmaceuticals, Inc.
First posted: 2022-09-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Patients will undergo stratified randomization based on BAN-ADHF score (0-11 vs. ≥ 12). Within each stratum, patients will be randomized in a 1:1 ratio (intervention: control).
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Pregnant
* 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

Primary outcomes:
measure: Post-treatment urine output as measured by cumulative urine output within 1 day.
timeFrame: 1 day
measure: Post-treatment spot urine sodium levels in 1 day
timeFrame: 1 day
Secondary outcomes:
measure: Number of participants with post-intervention need for emergency department visit or hospitalization
timeFrame: 7 days and 30 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Ambarish Pandey, MD, MSCS
role: PRINCIPAL_INVESTIGATOR
References: