Heart FailureNCT05015764
Reprieve Cardiovascular System for the Treatment of Subjects With Acute Decompensated Heart Failure Mechanistic Study
A study testing Fluid Management and Reprieve Cardiovascular System in people with Heart Failure, run by Reprieve Cardiovascular, Inc at 1 site in Georgia.
Trial summary
Reprieve Cardiovascular System for the Treatment of Subjects with Acute Decompensated Heart Failure Mechanistic Study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Fluid Management and Reprieve Cardiovascular System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteGeorgia
- Study dates
- 12 Apr 2021to 2 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized with a diagnosis of heart failure
- Patients ≥ 18 years of age able to provide informed consent and comply with study procedures.
Who cannot join
- 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
- Enrollment in another interventional trial during the index hospitalization
- Life expectancy less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Reprieve Cardiovascular System for the Treatment of Subjects with Acute Decompensated Heart Failure Mechanistic Study
Read the detailed description
The key objective of the trial was to provide an optimized decongestion treatment for subjects with acute decompensated heart failure and identify the critical parameters that could be incorporated into the design of the next generation of the Reprieve Cardiovascular System.
- Conditions
- Heart Failure
- Being tested
- Fluid Management, Reprieve Cardiovascular System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid ManagementOther
Removal of excess extracellular fluid using diuretics
Reprieve Cardiovascular SystemDevice
System with Fluid Management Module
| Study group | Role | What they receive |
|---|---|---|
| Reprieve Cardiovascular System | Experimental | Not described Receives: Device: Reprieve Cardiovascular System |
| Standard of Care | Active comparator | Not described Receives: Other: Fluid Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Excretion of Sodium measured during therapy
Average fractional excretion of sodium across all patients measured during therapy
Measured: End of treatment, an average of 24 hours
Device and Procedure related AEs and SAEs
Rate of device and procedure related AEs and SAEs
Measured: Through study completion, an average of 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start12 Apr 2021
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reprieve Cardiovascular, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015764
- Sponsor's protocol ID
- RCV-0005
- Status last verified
- Nov 2022
- First submitted
- 12 Jul 2021
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reprieve Cardiovascular System for the Treatment of Subjects With Acute Decompensated Heart Failure Mechanistic Study
- ClinicalTrials.gov ID
- NCT05015764
- Acronym / sponsor ID
- RCV-0005
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Reprieve Cardiovascular, IncIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reprieve Cardiovascular System for the Treatment of Subjects with Acute Decompensated Heart Failure Mechanistic Study
Detailed description
The key objective of the trial was to provide an optimized decongestion treatment for subjects with acute decompensated heart failure and identify the critical parameters that could be incorporated into the design of the next generation of the Reprieve Cardiovascular System.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reprieve Cardiovascular System | Experimental | Device: Reprieve Cardiovascular System |
| Standard of Care | Active comparator | Other: Fluid Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalized with a diagnosis of heart failure
- Patients ≥ 18 years of age able to provide informed consent and comply with study procedures.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid ManagementRemoval of excess extracellular fluid using diuretics | Other | Standard of Care |
| Reprieve Cardiovascular SystemSystem with Fluid Management Module | Device | Reprieve Cardiovascular System |
Primary outcome
Fractional Excretion of Sodium measured during therapy
Time frame: End of treatment, an average of 24 hours
Average fractional excretion of sodium across all patients measured during therapy
Device and Procedure related AEs and SAEs
Time frame: Through study completion, an average of 90 days
Rate of device and procedure related AEs and SAEs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid Management and Reprieve Cardiovascular System in people with Heart Failure, run by Reprieve Cardiovascular, Inc at 1 site in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional Excretion of Sodium measured during therapy (time frame: End of treatment, an average of 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.