EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU)

Acute Decompensated Heart Failure Clinical Trial

— FASTR-EU  

Official title:

EU Sites: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) (FASTR-EU)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362668
• Other study ID #: RCV-0006-EU
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 9, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Reprieve Cardiovascular, Inc
• Contact: Tony Fields
• Phone: 650-224-3884
• Email: tfields[@]reprievecardio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS 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 DMS is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign.

2. =10 pounds (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.

3. Prior use of loop diuretics within 30 says prior to admission.

Exclusion Criteria:

1. Inability to place Foley catheter or IV catheter.

2. Hemodynamic instability.

3. Dyspnea due primarily to non-cardiac causes.

4. Acute infection with evidence of systemic involvement.

5. Inability to follow instructions or comply with follow-up procedures.

6. Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures.

7. Severe electrolyte abnormalities.

8. Presence of active coronavirus disease 2019 (COVID-19) infection.

9. Enrollment in another interventional trial during the index hospitalization.

10. Inability of the patient to stand and obtain daily standing weights.

11. Inability to return for follow-up study visits.

12. Life expectancy less than 3 months.

13. Women who are pregnant or intend to become pregnant.

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Device:
• Reprieve Decongestion Management System
The Reprieve Decongestion Management System, or Reprieve DMS, is a hospital bedside fluid management console designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure.

Drug:
• Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide)
Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC).

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen
Poland	Wroclaw Medical University	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Reprieve Cardiovascular, Inc

Countries where clinical trial is conducted

Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sodium loss (in mmol of sodium) per 24 hours	Primary efficacy endpoint is total sodium loss in mmol of sodium at end of randomized therapy normalized to 24 hours (up to a maximum of 72 hours).	End of treatment, an average of 72 hours
Primary	Comparison of occurrence of composite endpoint comprised of clinically significant acute kidney injury, severe electrolyte abnormality, or symptomatic hypotension or hypertensive emergency.	Primary safety endpoint is positive if any of the following occurs in an individual participant: Clinically significant acute kidney injury defined as Kidney Disease-Improving Global Outcomes (KDIGO) stage 2 or greater Acute Kidney Injury (AKI) [= doubling of baseline serum creatinine or use of renal replacement therapy (RRT)]; Severe electrolyte abnormality defined as serum potassium <3.0 milliequivalent/liter (mEq/L), magnesium <1.3 mEq/L, or sodium <135 mEq; Symptomatic hypotension (systolic pressure <80mmHg) or hypertensive (systolic pressure >200 mmHg and/or diastolic pressure >120 mmHg) emergency.	Through study completion, an average of 90 days
Secondary	Total net fluid volume loss (difference between urine output volume and fluid input volume) per 24 hours	Difference between volume of urine output and fluid input during primary treatment normalized to 24 hours.	End of treatment, an average of 72 hours
Secondary	Weight loss per 24 hours at end of randomized therapy	Total time on loop diuretics during primary treatment	End of treatment, an average of 72 hours
Secondary	Time on IV loop diuretic	Total time on loop diuretics from initiation of randomized therapy to last dose of IV loop diuretic administered for ADHF	End of treatment, an average of 72 hours
Secondary	Number of participants with = 0.3 mg/dL increase in serum creatinine	In hospital worsening renal function defined as = 0.3 mg/dL increase in serum creatinine during randomized therapy.	End of treatment, an average of 72 hours