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Loop Diuretic
Furoscix for Heart Failure (RESISTANCE-HF Trial)
Phase 2
Recruiting
Led By Ambarish Pandey, MD, MSCS
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
RESISTANCE-HF Trial Summary
This trial is testing whether the drug Furoscix is more effective than standard care at helping people with heart failure who retain fluid. This will be measured by urine sodium levels.
Who is the study for?
This trial is for English-speaking patients recently hospitalized for acute decompensated heart failure with specific blood markers, who can be screened within two weeks of hospital discharge and have a recent echocardiogram. It's not for those with severe kidney disease, very low blood pressure, recent ICU stay or inotrope use, pregnant women, certain other health conditions or treatments.Check my eligibility
What is being tested?
The study tests if Furoscix is better at removing excess fluid from the body compared to standard diuretic therapy in heart failure patients. Participants are split into groups by chance to receive either Furoscix or their usual care. The main measure of success is how much urine they produce after treatment.See study design
What are the potential side effects?
Potential side effects of Furoscix may include dehydration, electrolyte imbalances (like low potassium), low blood pressure, dizziness upon standing up quickly (orthostatic hypotension), and possible skin irritation where the medication is applied.
RESISTANCE-HF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-treatment diuretic efficiency as measured by cumulative urine output within 1 day.
Post-treatment diuretic efficiency as measured by spot urine sodium levels in 1 day
Secondary outcome measures
Number of participants with post-intervention need for emergency department visit or hospitalization
RESISTANCE-HF Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: > 11 BAN-ADHF, FuroscixExperimental Treatment1 Intervention
Patients with diuretic resistance as determined by a BAN-ADHF score > 11 will receive Furoscix over 5 hours at 8 mg/mL.
Group II: <= 11 BAN-ADHF, FuroscixExperimental Treatment1 Intervention
Patients without diuretic resistance as determined by BAN-ADHF score <= 11 will receive Furoscix over 5 hours at 8 mg/mL.
Group III: <= 11 BAN-ADHF, controlActive Control1 Intervention
Patients without diuretic resistance as determined by BAN-ADHF score <= 11 will receive home dose oral diuretic
Group IV: > 11 BAN-ADHF, controlActive Control1 Intervention
Patients with diuretic resistance as determined by a BAN-ADHF score > 11 will receive home dose oral diuretic.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,741 Total Patients Enrolled
23 Trials studying Heart Failure
13,269 Patients Enrolled for Heart Failure
scPharmaceuticals, Inc.Industry Sponsor
11 Previous Clinical Trials
339 Total Patients Enrolled
9 Trials studying Heart Failure
282 Patients Enrolled for Heart Failure
Ambarish Pandey, MD, MSCSPrincipal InvestigatorUT Southwestern Medical Center
2 Previous Clinical Trials
140 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am severely malnourished.I speak English and was hospitalized for worsening heart failure with high NT-proBNP levels.I have been diagnosed with low-output heart failure.My condition is advanced liver disease.Your top blood pressure number is less than 100.My kidney function is very low or I am in the final stage of kidney disease.There is not enough information about your BAN-ADHF score.I have not been in the ICU in the last 3 months.I can join the study within 14 days of being hospitalized.You are currently using inotropic medications at home.I have not used inotropes in the last 3 months.You have had a heart transplant or have a left ventricular assist device.You had an echocardiogram within the past 6 months.I have been prescribed diuretics to take at home.I am currently taking a diuretic that is not a loop diuretic.You have abnormal levels of electrolytes in your body when you leave the hospital.I do not have skin conditions that prevent Furoscix use.I cannot collect my urine.
Research Study Groups:
This trial has the following groups:- Group 1: <= 11 BAN-ADHF, Furoscix
- Group 2: <= 11 BAN-ADHF, control
- Group 3: > 11 BAN-ADHF, Furoscix
- Group 4: > 11 BAN-ADHF, control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical trial have availability for recruitment?
"Contemporary information from clinicaltrials.gov states that recruitment for this trial has been suspended, as it was initially posted on January 1st 2023 and the last update took place October 17th 2022. Nevertheless, there are 700 other studies recruiting patients currently."
Answered by AI
Has the Food and Drug Administration sanctioned Furoscix for use?
"Despite limited evidence on its efficacy, Furoscix's safety profile has been estimated to score a 2. This is based upon clinic data showing that the drug appears relatively safe."
Answered by AI
Am I eligible to be a participant in this experiment?
"To qualify for this trial, the applicant must have a diagnosis of heart failure and be between 18 to 80 years old. At present, there is an opening for 60 participants."
Answered by AI
Does the research involve individuals aged 55 and over?
"This trial is available for applicants between the ages of 18 and 80. 22 clinical trials are designed for those under 18, whereas 690 studies have been created to assist people over 65 years old."
Answered by AI
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