Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)

Acute Decompensated Heart Failure Clinical Trial

— FASTR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05174312
• Other study ID #: RCV-0006
• Status: Recruiting
• Phase: N/A
• Start date: July 11, 2022
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Reprieve Cardiovascular, Inc
• Contact: Arslan Malik
• Phone: 7072371616
• Email: amalik[@]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 can more efficiently decongest ADHF patients in comparison to Control Therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2024
• Est. primary completion date: June 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 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
Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC).

Locations

Country	Name	City	State
United States	Ascension Texas Cardiovascular	Austin	Texas
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Prisma Health	Columbia	South Carolina
United States	Duke University Hospital	Durham	North Carolina
United States	Cone Health	Greensboro	North Carolina
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Reprieve Cardiovascular, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total urine sodium output	Primary efficacy endpoint is total urine sodium output at 24 hours post-treatment initiation.	24 hours post-treatment initiation
Primary	Clinically significant acute kidney injury, severe electrolyte abnormality, symptomatic hypotension or hypertensive emergency.	Primary safety endpoint includes clinically significant acute kidney injury defined as KDIGO stage 2 or greater AKI [= doubling of baseline serum creatinine or use of renal replacement therapy (RRT)], severe electrolyte abnormality (serum potassium <3.0 mEq/L, magnesium <1.3 mEq/L or sodium <125 mEq), symptomatic hypotension or hypertensive emergency.	Through study completion, an average of 90 days
Secondary	Net fluid loss	Difference in the amount of net fluid removed during primary treatment	End of treatment, an average of 72 hours
Secondary	Time on loop diuretics	Total time on loop diuretics during primary treatment	End of treatment, an average of 72 hours