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Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)

Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II)

NCT06898515•Reprieve Cardiovascular, Inc

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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 treatment
•2. ≥10 lb. (4.5 kg) above dry weight as estimated by health care provider.
•3. Current outpatient prescription for daily loop diuretic.
•4. Participants ≥ 22 years of age able to provide informed consent and comply with study procedures.
•5. Elevated risk of diuretic resistance, as indicated by at least one of the following: Baseline hypochloremia OR Urine output \<1L in the 6 hours following IV loop diuretic \>=40 mg furosemide equivalent OR Spot urine sodium \<100 mmol/L 1-2 hours after IV loop diuretic \>= 40 mg furosemide equivalent

Exclusion Criteria

•1. 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.
•2. Hemodynamic instability as defined by any of the following: sustained systolic blood pressure \<90 mmHg for \>15 minutes within the past 48 hours, use of IV vasopressors or inotropes within past 48 hours, and/or current or previous mechanical circulatory support within the last week.
•3. Uncontrolled arrhythmias defined as sustained HR \>130 beats/min for \>10 minutes within the past 48 hours.
•4. Severe lung disease with chronic home oxygen requirement \>2L/min.
•5. Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).
•6. 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).
•7. 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 would make aggressive decongestion unsafe.
•8. 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., from volume overload or demand ischemia) is not a reason for exclusion.
•9. 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 cannot be reassessed for inclusion in the trial.
•10. 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 reasons other than decongestive therapy
+3 more criteria

Locations (53)

University of California Irvine

Irvine, California, United States

Scripps Memorial Hospital

La Jolla, California, United States

UC Davis Medical Center

Sacramento, California, United States

University of Florida

Gainesville, Florida, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Piedmont Augusta Hospital

Augusta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Louisville Hospital

Louisville, Kentucky, United States

Key Dates

Start Date

July 14, 2025

Primary Completion Date

August 1, 2027

Completion Date

December 1, 2027

Last Updated

November 26, 2025

Enrollment

400

ESTIMATED participants

Conditions

Acute Decompensated Heart Failure

Interventions

Reprieve System

DEVICE

furosemide infusion

DRUG

Contacts

Annemarie Forrest

CONTACT

617-848-0400 aforrest@reprievecardio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)

Inclusion Criteria

Exclusion Criteria

Add-on Diuretics in Acute Decompensated Heart Failure

Comparative Efficacy and Safety of Acetazolamide Versus Metolazone as an Adjunct to Standard Therapy in Patients With Acute Decompensated Heart Failure

EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF

Adherence to Medication in Patients With Acute Decompensated Heart Failure

Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study

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