Chronic Heart FailureREFORM-HFNCT06360380
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
A study testing AquaPass System in people with Chronic Heart Failure and CKD Stage 3, run by AquaPass Medical Ltd. at 10 sites in 2 countries.
Trial summary
The REFORM-HF study aims to test a new technology, AQUAPASS, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure. Patients will wear a lightweight suit that helps remove excess fluids through their sweat. Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Chronic Heart Failure, CKD Stage 3
- What is being tested?
- AquaPass System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 12 Aug 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥21 years and < 80 years
- Subject, with known decompensated heart failure NYHA Class II, III (as evaluated by an independent observer who is not on the study team) presenting with fluid overload, defined by a congestion score of ≥3, who are not responding adequately or are resistant to current medical treatment as evidenced by persistent or worsening congestion, despite a daily dose of 80 mg furosemide or greater or the equivalent dose of another loop diuretic .
- No change in diuretic dosage in the past 5 days
- Subjects with eGFR between 15-89 mL/min/1.73m2
- Baseline NT-proBNP ≥600 pg/mL
- Baseline systolic blood pressure ≥100 mmHg
- Subject is able and willing to provide written informed consent, inclusive of the release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation
- Subject is not participating in any clinical investigation that may interfere with the data collection or the results of this study
Who cannot join
- Subject considered to be in the acute worsening of heart failure: Requiring invasive or non-invasive mechanical ventilation, mechanical circulatory support or is clinically unstable requiring pressors, inotropes, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload .
- Subject has any known or visible lower body (non-facial) skin condition (open wounds, ulcers, infections) that can potentially prevent using the wearable for the duration of the procedure
- Known allergy to Polyester or Thermoplastic polyurethane (TPU)
- Subject with severe peripheral arterial disease
- Subject is pregnant or planning to become pregnant within the study period, or a lactating woman.
- Subject with known hypothalamic disorders
Show all 16Show fewer
- Subject with known hypohidrosis disorders
- Subjects with external medical technology dependency (gastric (G) tubes, ventilators, peripherally inserted central venous catheters, etc.)
- Subject with cystic fibrosis
- Subject with active infections
- Inability or unwillingness to comply with the study requirements
- Subjects with unstable electrolytes or acid-base balance (as per investigator's discretion)
- Known Severe aortic valve or mitral valve stenosis
- History of a heart transplant or actively listed for a heart transplant
- Implanted left ventricular assist device (LVAD) or implant anticipated in <3 months
- Subject with a life expectancy of less than 6 months, per investigator's discretion, due to malignant or non-cardiac comorbidities
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States8 sites, 8 recruiting
- Recruiting
Mission Hospital
Asheville, North Carolina, 28801
Vinay Thohan, MD, 828-412-9149, vinay.thohan@hcahealthcare.com
Vinay Thohan, MD
- Recruiting
Austin Heart Hospital
Austin, Texas, 78705
Kunjan Bhatt, MD, 512-206-3600, kbhatt@austinheart.com
Kunjan Bhatt, MD
- Recruiting
Cone Health Advanced Heart Failure Clinic at Moses Cone
Greensboro, North Carolina, 27401
Benjamin Stoner, MD, benjamin.stoner@conehealth.com
Benjamin Stoner, MD
- Recruiting
UC San Diego Health-Sulpizio Cardiovascular Center
La Jolla, California, 92037
Ori Ben-Yehuda, MD, 858-246-2413, obenyehuda@health.ucsd.edu
Ori Ben-Yehuda, MD
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Tamas Alexy, MD, 612-626-1240, alexy001@umn.edu
Gretchen Peichel, RN-CRC, 612-626-6237, gpeichel@umn.edu
- Recruiting
Northwell Health- Lenox Hill Hospital
New York, New York, 10075
Gerin Stevens, MD, 516-562-1428, gstevens1@northwell.edu
Virgenmina Lugaro, 212-434-6626, vlugaro@northwell.edu
- Recruiting
Rochester Regional Health
Rochester, New York, 14621
Scott C Feitell, DO, (585) 442 5320, Scott.Feitell@rochesterregional.org
Kara Cristales, RN, kara.cristales@rochesterregional.org
- Recruiting
UC San Francisco
San Francisco, California, 94143
Liviu Klein, MD, 619-972-4251, liviu.klein@ucsf.edu
Liviu Klein, MD
Israel2 sites, 2 recruiting
- Recruiting
Rambam Medical Campus
Haifa, 3109601
Doron Aronson, MD, PhD, 972-4-777-2342, d_aronson@rambam.health.gov.il
- Recruiting
Rabin Medical Center
Petah Tikva, 49100
Tuvia Ben Gal, MD, bengaltu@gmail.com
About this study
Official title: REFORM-HF™ Reducing Fluid Overload Using Renal Independent systeM in Heart Failure Patients
The REFORM-HF study aims to test a new technology, AQUAPASS, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.
Patients will wear a lightweight suit that helps remove excess fluids through their sweat.
The investigators want to see if the AQUAPASS system can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics.
Participants will be treated in the hospital or in the outpatient clinic.
Read the detailed description
This study is being conducted to demonstrate the safety and effectiveness of the AquaPass System in reducing fluid overload in patients with decompensated heart failure and chronic kidney disease stage 2-3 who are not responding adequately or resistant to current medical treatment.
The study checks if patients' fluid loss as a result of taking diuretics medications is improved when using AQUAPASS in parallel to this treatment.
The evaluation of success is done by comparing participants' weight before and after the use of the AQUAPASS system, to evaluate if the system effectively removes excess fluids.
Patients will also have blood and urine tests every morning to check how well their kidneys and heart are functioning.
The first visit will be observation only, without using AQUAPASS. This will serve as the baseline data. The investigators will compare the data of the AQUAPASS treatments with this baseline to measure the effectiveness of the system in removing excess fluids.
- Conditions
- Chronic Heart Failure, CKD Stage 3
- Being tested
- AquaPass System
- Keywords
- Aquapass, Sweat Enhancement, Fluid removal, CHF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquaPass SystemDevice
a treatment session of up to 5 hours with the AquaPass system, evaluating net fluid removal for efficacy analysis and effect on vital signs for safety analysis
| Study group | Role | What they receive |
|---|---|---|
| AquaPass | Experimental | An AquaPass treatment session (up to 5-Hrs.) will be administered and supervised by certified study staff Receives: Device: AquaPass System |
| Control | No intervention | An observation visit, during which data will be collected on fluid intake, fluid output, congestion score, and body weight. These data will serve as a control for the efficacy primary endpoint comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AQUAPASS Performance Evaluation
Average Net Fluid Loss calculated as the difference in weight between pre- and post-AQUAPASS treatment sessions, in comparison to the Control Day observation.
Total Average Net Fluid Loss during the Treatment Phase should be ≥ 500gr. as compared to the Total Average Net Fluid Loss during the Control Phase.
Measured: 5 days
Secondary outcomes (1)
AQUAPASS Safety Evaluation
Incidence of device- and procedure-related side effects - defined as ANY of the following events during or immediately after device use:
- loss of consciousness
- acute confusion/disorientation
- cardiac arrest
- respiratory failure or seizure
- decrease in systolic blood pressure ≥ 20 mmHg OR mean BP ≥ 10 mmHg WITH associated symptoms (cramping, headache, lightheadedness, vomiting, or chest pain) AND need for intervention (administration of fluids)
- skin infections
- skin burns
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start12 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- A prospective, multicenter, single-arm, within-subject-controlled, pivotal trial, enrolling subjects with decompensated heart failure inadequately responding to current medical treatment, indicated by persistent or worsening congestion despite a daily dose of ≥80 mg furosemide or equivalent loop diuretics.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AquaPass Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott C Feitell, DO, Principal investigator, Rochester Regional Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360380
- Sponsor's protocol ID
- AQP-CLP-004
- Acronym
- REFORM-HF
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REFORM-HF™ Reducing Fluid Overload Using Renal Independent systeM in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT06360380
- Acronym / sponsor ID
- REFORM-HF / AQP-CLP-004
- Conditions
- Chronic Heart Failure, CKD Stage 3
- Keywords
- Aquapass, Sweat Enhancement, Fluid removal, CHF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AquaPass Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 Apr 2024 (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 REFORM-HF study aims to test a new technology, AQUAPASS, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.
Patients will wear a lightweight suit that helps remove excess fluids through their sweat.
The investigators want to see if the AQUAPASS system can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics.
Participants will be treated in the hospital or in the outpatient clinic.
Detailed description
This study is being conducted to demonstrate the safety and effectiveness of the AquaPass System in reducing fluid overload in patients with decompensated heart failure and chronic kidney disease stage 2-3 who are not responding adequately or resistant to current medical treatment.
The study checks if patients' fluid loss as a result of taking diuretics medications is improved when using AQUAPASS in parallel to this treatment.
The evaluation of success is done by comparing participants' weight before and after the use of the AQUAPASS system, to evaluate if the system effectively removes excess fluids.
Patients will also have blood and urine tests every morning to check how well their kidneys and heart are functioning.
The first visit will be observation only, without using AQUAPASS. This will serve as the baseline data. The investigators will compare the data of the AQUAPASS treatments with this baseline to measure the effectiveness of the system in removing excess fluids.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, multicenter, single-arm, within-subject-controlled, pivotal trial, enrolling subjects with decompensated heart failure inadequately responding to current medical treatment, indicated by persistent or worsening congestion despite a daily dose of ≥80 mg furosemide or equivalent loop diuretics.
| Arm | Type | Receives |
|---|---|---|
| AquaPass | Experimental | Device: AquaPass SystemAn AquaPass treatment session (up to 5-Hrs.) will be administered and supervised by certified study staff |
| Control | No intervention | –An observation visit, during which data will be collected on fluid intake, fluid output, congestion score, and body weight. These data will serve as a control for the efficacy primary endpoint comparison. |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥21 years and < 80 years
- Subject, with known decompensated heart failure NYHA Class II, III (as evaluated by an independent observer who is not on the study team) presenting with fluid overload, defined by a congestion score of ≥3, who are not responding adequately or are resistant to current medical treatment as evidenced by persistent or worsening congestion, despite a daily dose of 80 mg furosemide or greater or the equivalent dose of another loop diuretic .
- No change in diuretic dosage in the past 5 days
- Subjects with eGFR between 15-89 mL/min/1.73m2
- Baseline NT-proBNP ≥600 pg/mL
Key exclusion criteria (16 listed)
- Subject considered to be in the acute worsening of heart failure: Requiring invasive or non-invasive mechanical ventilation, mechanical circulatory support or is clinically unstable requiring pressors, inotropes, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload .
- Subject has any known or visible lower body (non-facial) skin condition (open wounds, ulcers, infections) that can potentially prevent using the wearable for the duration of the procedure
- Known allergy to Polyester or Thermoplastic polyurethane (TPU)
- Subject with severe peripheral arterial disease
- Subject is pregnant or planning to become pregnant within the study period, or a lactating woman.
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 |
|---|---|---|
| AquaPass Systema treatment session of up to 5 hours with the AquaPass system, evaluating net fluid removal for efficacy analysis and effect on vital signs for safety analysis | Device | AquaPass |
Primary outcome
AQUAPASS Performance Evaluation
Time frame: 5 days
Average Net Fluid Loss calculated as the difference in weight between pre- and post-AQUAPASS treatment sessions, in comparison to the Control Day observation. Total Average Net Fluid Loss during the Treatment Phase should be ≥ 500gr. as compared to the Total Average Net Fluid Loss during the Control Phase.
1 secondary outcome
AQUAPASS Safety Evaluation
Time frame: 6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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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.
Scott C Feitell, DO principal investigator
Rochester Regional Health
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AquaPass System in people with Chronic Heart Failure and CKD Stage 3, run by AquaPass Medical Ltd. at 10 sites in 2 countries.
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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott C Feitell, DO ((585) 442 5320, scott.feitell@rochesterregional.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AQUAPASS Performance Evaluation (time frame: 5 days). 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 6 Jul 2026.