NCT06898515 Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
| NCT ID | NCT06898515 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Reprieve Cardiovascular, Inc |
| Condition | Acute Decompensated Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-07-14 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2025-07-14 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 11. Currently enrolled in an interventional trial (observational studies are permitted). 12. Life expectancy less than 6 months. 13. Women who are pregnant or breastfeeding.
Contact & Investigator
Javed Butler, MD, MPH, MBA
PRINCIPAL INVESTIGATOR
Baylor Scott and White Health
Frequently Asked Questions
Who can join the NCT06898515 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Acute Decompensated Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06898515 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT06898515 currently recruiting?
Yes, NCT06898515 is actively recruiting participants. Contact the research team at aforrest@reprievecardio.com for enrollment information.
Where is the NCT06898515 trial being conducted?
This trial is being conducted at Irvine, United States, La Jolla, United States, Sacramento, United States, Gainesville, United States and 11 additional locations.
Who is sponsoring the NCT06898515 clinical trial?
NCT06898515 is sponsored by Reprieve Cardiovascular, Inc. The principal investigator is Javed Butler, MD, MPH, MBA at Baylor Scott and White Health. The trial plans to enroll 400 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.