Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05528588
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2022-08-31
Brief Title:
Furoscix in Heart Failure Patients With Diuretic Resistance
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Efficacy of Furoscix in Heart Failure Patients With Diuretic Resistance
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESISTANCE-HF
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 11552 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 11 ratio intervention control The intervention arm Furoscix over 5 hours at 8mgmL 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
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 11 ratio intervention control The intervention arm Furoscix over 5 hours at 8mgmL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None