Heart Failure (for Example, Fluid Overload)REVERSE-HFNCT05318105
Ultrafiltration Versus IV Diuretics in Worsening Heart Failure
A study testing Aquadex Smartflow® System and IV Loop Diuretics in people with Heart Failure (for Example, Fluid Overload) and Heart Failure, run by Nuwellis, Inc. at 15 sites in United States.
Trial summary
The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure (for Example, Fluid Overload), Heart Failure, Fluid Overload
- What is being tested?
- Aquadex Smartflow® System and IV Loop Diuretics
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 15 sitesUnited States
- Study dates
- 28 Jun 2022to 7 Apr 2026
- 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
- 18 years or older
- Man, or non-pregnant woman
- Admitted to the hospital with a diagnosis of acute decompensated heart failure
- On regularly prescribed oral loop diuretics, Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors or a Mineralcorticoid Receptor Antagonists (MRA) prior to admission
- Fluid overload manifested by at least three clinical indications (e.g., edema, an excess of at least 10 pounds of fluid, etc.)
- Provide written informed consent
Who cannot join
- New diagnosis of heart failure
- Acute coronary syndromes
- Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment
- Contraindications to systemic anticoagulation
- Severe concomitant disease expected to prolong hospitalization or cause death in less than 90 days
- Sepsis or ongoing systemic infection
Show all 10Show fewer
- Active myocarditis
- Constrictive pericarditis or restrictive cardiomyopathy
- Severe aortic stenosis
- Any condition in the opinion of the investigator that would prevent the patient from follow-up/survival
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Abington Jefferson Health
Abington, Pennsylvania, 19001
The Christ Hospital
Cincinnati, Ohio, 45219
BayCare Medical Group, Morton Plant
Clearwater, Florida, 33756
The Ohio State University
Columbus, Ohio, 43215
Baylor Scott & White Research Institute
Dallas, Texas, 75207
Henry Ford Health
Detroit, Michigan, 48202
Jackson Madison County General Hospital
Jackson, Tennessee, 38301
University of Kentucky
Lexington, Kentucky, 40536
MemorialCare, Long Beach Medical Center
Long Beach, California, 90806
Mount Sinai Morningside
New York, New York, 10025
The Mount Sinai Hospital
New York, New York, 10029
Northwell Health
New York, New York, 10075
Sentara Norfolk General Heart Hospital
Norfolk, Virginia, 23507
Sharp Memorial Hospital, San Diego Cardiac Center
San Diego, California, 92123
Banner Health
Tucson, Arizona, 85721
About this study
Official title: A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload
The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload.
- Being tested
- Aquadex Smartflow® System, IV Loop Diuretics
- Keywords
- Heart failure, Fluid overload
- Medical subject headings
- Heart Failure, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquadex Smartflow® SystemDevice
ultrafiltration
IV Loop DiureticsDrug
diuretics
| Study group | Role | What they receive |
|---|---|---|
| Aquadex ultrafiltration therapy | Experimental | Not described Receives: Device: Aquadex Smartflow® System |
| IV loop diuretics | Active comparator | Not described Receives: Drug: IV Loop Diuretics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first heart failure (HF) event
Heart Failure (HF) event defined as any HF rehospitalization or unplanned use of IV loop diuretics, vasoactive medications or Aquadex therapy in any outpatient setting.
Measured: within 30 days
Secondary outcomes (1)
Win ratio analysis
Win ratio analysis of cardiovascular (CV) mortality, HF events and quality of life
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start28 Jun 2022
- Primary completion6 Oct 2025
- Study completion7 Apr 2026
Why it stopped: The study was stopped early due to slow enrollment and was a business decision. This decision was not based on any efficacy or safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure (for Example, Fluid Overload)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuwellis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Pinney, MD, Principal investigator, Mount Sinai MorningsideMaria DeVita, MD, FASN, Principal investigator, Lenox Hill Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318105
- Sponsor's protocol ID
- CLIN07687
- Acronym
- REVERSE-HF
- Status last verified
- Jun 2026
- First submitted
- 10 Mar 2022
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
McCallum W, Sarnak MJ. Cardiorenal Syndrome in the Hospital. Clin J Am Soc Nephrol. 2023 Jul 1;18(7):933-945. doi: 10.2215/CJN.0000000000000064. Epub 2023 Jan 13.
PubMed 36787124
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload
- ClinicalTrials.gov ID
- NCT05318105
- Acronym / sponsor ID
- REVERSE-HF / CLIN07687
- Keywords
- Heart failure, Fluid overload
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped early due to slow enrollment and was a business decision. This decision was not based on any efficacy or safety concerns.
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Nuwellis, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 8 Apr 2022 (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.
The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquadex ultrafiltration therapy | Experimental | Device: Aquadex Smartflow® System |
| IV loop diuretics | Active comparator | Drug: IV Loop Diuretics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Man, or non-pregnant woman
- Admitted to the hospital with a diagnosis of acute decompensated heart failure
- On regularly prescribed oral loop diuretics, Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors or a Mineralcorticoid Receptor Antagonists (MRA) prior to admission
- Fluid overload manifested by at least three clinical indications (e.g., edema, an excess of at least 10 pounds of fluid, etc.)
Key exclusion criteria (10 listed)
- New diagnosis of heart failure
- Acute coronary syndromes
- Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment
- Contraindications to systemic anticoagulation
- Severe concomitant disease expected to prolong hospitalization or cause death in less than 90 days
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 |
|---|---|---|
| Aquadex Smartflow® Systemultrafiltration | Device | Aquadex ultrafiltration therapy |
| IV Loop Diureticsdiuretics | Drug | IV loop diuretics |
Primary outcome
Time to first heart failure (HF) event
Time frame: within 30 days
Heart Failure (HF) event defined as any HF rehospitalization or unplanned use of IV loop diuretics, vasoactive medications or Aquadex therapy in any outpatient setting.
1 secondary outcome
Win ratio analysis
Time frame: within 30 days
Results and safety
The study was stopped early (reason given: The study was stopped early due to slow enrollment and was a business decision. This decision was not based on any efficacy or safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Derived from this study: PubMed 36787124McCallum W, Sarnak MJ. Cardiorenal Syndrome in the Hospital. Clin J Am Soc Nephrol. 2023 Jul 1;18(7):933-945. doi: 10.2215/CJN.0000000000000064. Epub 2023 Jan 13.
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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.
Sean Pinney, MD principal investigator
Mount Sinai Morningside
Maria DeVita, MD, FASN principal investigator
Lenox Hill Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquadex Smartflow® System and IV Loop Diuretics in people with Heart Failure (for Example, Fluid Overload) and Heart Failure, run by Nuwellis, Inc. at 15 sites in United States.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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 was stopped early (reason given: The study was stopped early due to slow enrollment and was a business decision. This decision was not based on any efficacy or safety concerns.). Results are not available in the source record.
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?
Time to first heart failure (HF) event (time frame: within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05318105, which also lists 1 linked publication.
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 25 Jun 2026.