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

Primary Purpose

Acute Decompensated Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reprieve Decongestion Management System
Diuretic
Sponsored by
Reprieve Cardiovascular, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Decompensated Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 with a total daily dose of 80 mg to 400 mg furosemide equivalents for a minimum of 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.

Sites / Locations

  • Cone HealthRecruiting
  • Prisma HealthRecruiting
  • University of VermontRecruiting
  • Sentara Norfolk General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reprieve Decongestion Management System

Optimal Diuretic Therapy

Arm Description

Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.

Subjects randomized to the control group will receive Optimal diuretic therapy, which will be based on the DOSE-AHF 'high dose' strategy which is the use of IV loop diuretic at 2.5 times the home dose of oral loop diuretic during the course of the treatment.

Outcomes

Primary Outcome Measures

Efficient decongestion
Primary efficacy endpoint is Efficient decongestion defined as the average rate of weight loss during the IV therapy (i.e., initial randomized IV diuretic dose to the cessation of IV therapy)
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.

Secondary Outcome Measures

Change in weight
Difference in weight at the end of primary treatment
Time on loop diuretics
Total time on loop diuretics during primary treatment

Full Information

First Posted
December 6, 2021
Last Updated
November 2, 2022
Sponsor
Reprieve Cardiovascular, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05174312
Brief Title
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)
Acronym
FASTR
Official Title
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) - FASTR Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reprieve Cardiovascular, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reprieve Decongestion Management System
Arm Type
Experimental
Arm Description
Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
Arm Title
Optimal Diuretic Therapy
Arm Type
Active Comparator
Arm Description
Subjects randomized to the control group will receive Optimal diuretic therapy, which will be based on the DOSE-AHF 'high dose' strategy which is the use of IV loop diuretic at 2.5 times the home dose of oral loop diuretic during the course of the treatment.
Intervention Type
Device
Intervention Name(s)
Reprieve Decongestion Management System
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Diuretic
Intervention Description
Subjects will receive diuretic therapy per the high dose of arm of the DOSE trial when randomized to the control group.
Primary Outcome Measure Information:
Title
Efficient decongestion
Description
Primary efficacy endpoint is Efficient decongestion defined as the average rate of weight loss during the IV therapy (i.e., initial randomized IV diuretic dose to the cessation of IV therapy)
Time Frame
End of treatment, an average of 72 hours
Title
Clinically significant acute kidney injury, severe electrolyte abnormality, symptomatic hypotension or hypertensive emergency.
Description
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.
Time Frame
Through study completion, an average of 90 days
Secondary Outcome Measure Information:
Title
Change in weight
Description
Difference in weight at the end of primary treatment
Time Frame
End of treatment, an average of 72 hours
Title
Time on loop diuretics
Description
Total time on loop diuretics during primary treatment
Time Frame
End of treatment, an average of 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign. ≥10 pounds (4.5 kg) above dry weight either by historical weights or as estimated by health care provider. Prior use of loop diuretics with a total daily dose of 80 mg to 400 mg furosemide equivalents for a minimum of 30 says prior to admission. Exclusion Criteria: Inability to place Foley catheter or IV catheter. Hemodynamic instability. Dyspnea due primarily to non-cardiac causes. Acute infection with evidence of systemic involvement. Inability to follow instructions or comply with follow-up procedures. 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. Severe electrolyte abnormalities. Presence of active COVID-19 infection. Enrollment in another interventional trial during the index hospitalization. Inability of the patient to stand and obtain daily standing weights. Inability to return for follow-up study visits. Life expectancy less than 3 months. Women who are pregnant or intend to become pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arslan Malik
Phone
7072371616
Email
amalik@reprievecardio.com
Facility Information:
Facility Name
Cone Health
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Individual Site Status
Recruiting
Facility Name
Prisma Health
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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