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New treatment option for Acute Decompensated Heart Failure
Official title Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
ClinicalTrials.gov ID: NCT06898515
What this study is testing
What is furosemide infusion?
furosemide infusion is an investigational medicine, being studied as a potential treatment for acute decompensated heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve 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 System can more efficiently decongest ADHF patients in comparison to Control Therapy.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Diagnosis of HF with expected hospitalization \>24 hours, with \>1 new or worsening symptom and \>2 physical examination, laboratory, or invasive...
- ≥10 lb. (4.5 kg) above dry weight as estimated by health care provider.
- Current outpatient prescription for daily loop diuretic.
- Participants ≥ 22 years of age able to provide informed consent and comply with study procedures.
- Elevated risk of diuretic resistance, as indicated by at least one of the following: Baseline hypochloremia OR Urine output \ =40 mg furosemide...
You likely can't join if
- Urologic issues that would predispose the participant to a high rate of urogenital trauma or infection with catheter placement or known inability to...
- Hemodynamic instability as defined by any of the following: sustained systolic blood pressure \ 15 minutes within the past 48 hours, use of IV...
- Uncontrolled arrhythmias defined as sustained HR \>130 beats/min for \>10 minutes within the past 48 hours.
- Severe lung disease with chronic home oxygen requirement \>2L/min.
- Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).
- Estimated glomerular filtration rate (eGFR) \<25 ml/min/1.73m2 (calculated with either MDRD or CKD-EPI) or current use of renal replacement therapy...
See the full eligibility criteria
- Diagnosis of HF with expected hospitalization \>24 hours, with \>1 new or worsening symptom and \>2 physical examination, laboratory, or invasive findings of HF, and receiving or with plans to receive a HF-specific...
- ≥10 lb. (4.5 kg) above dry weight as estimated by health care provider.
- Current outpatient prescription for daily loop diuretic.
- Participants ≥ 22 years of age able to provide informed consent and comply with study procedures.
- Elevated risk of diuretic resistance, as indicated by at least one of the following: Baseline hypochloremia OR Urine output \ =40 mg furosemide equivalent OR Spot urine sodium \ = 40 mg furosemide equivalent
- Urologic issues that would predispose the participant to a high rate of urogenital trauma or infection with catheter placement or known inability to place a Foley catheter.
- Hemodynamic instability as defined by any of the following: sustained systolic blood pressure \ 15 minutes within the past 48 hours, use of IV vasopressors or inotropes within past 48 hours, and/or current or previous...
- Uncontrolled arrhythmias defined as sustained HR \>130 beats/min for \>10 minutes within the past 48 hours.
- Severe lung disease with chronic home oxygen requirement \>2L/min.
- Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).
- Estimated glomerular filtration rate (eGFR) \<25 ml/min/1.73m2 (calculated with either MDRD or CKD-EPI) or current use of renal replacement therapy (RRT).
- Significant left ventricular outflow obstruction, severe uncorrected complex congenital heart disease, known severe stenotic valvular disease, severe infiltrative or constrictive cardiomyopathy or other diagnosis that...
- Current or recent (\< 30 days) type I myocardial infarction (e.g., acute coronary syndrome such as NSTEMI or STEMI from plaque rupture), coronary artery bypass surgery, or stroke. An isolated troponin elevation (e.g...
- Severe electrolyte abnormalities (e.g., serum potassium \<3.0 mEq/L, magnesium \<1.3 mEq/L or sodium \<125 mEq/L). Note: These are based on baseline/screening labs. Participants whose electrolyte levels are repleted...
- Other concomitant disease or condition the investigator believes will make it difficult to follow instructions or comply with study procedures and/or follow-up visits, including expected prolonged hospitalization for...
- Currently enrolled in an treatment trial (observational studies are permitted).
- Life expectancy less than 6 months.
- Women who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- La Jolla, California, United States
- Sacramento, California, United States
- Gainesville, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Gainesville, Georgia, United States
- Oak Lawn, Illinois, United States
- Kansas City, Kansas, United States
- Louisville, Kentucky, United States
- Ann Arbor, Michigan, United States
- Grand Rapids, Michigan, United States
- Royal Oak, Michigan, United States
- Minneapolis, Minnesota, United States
- Jackson, Mississippi, United States
- Columbia, Missouri, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Stony Brook, New York, United States
- Durham, North Carolina, United States
+ 27 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; La Jolla, California, United States; Sacramento, California, United States; Gainesville, Florida, United States; Atlanta, Georgia, United States; Augusta, Georgia, United States and 41 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.