Chronic Heart FailureREFORM-HF IINCT06401109
Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients, a European Registry
A study testing AquaPass in people with Chronic Heart Failure and Fluid Overload, run by AquaPass Medical Ltd..
Trial summary
The AquaPass is a non-invasive, renal-intended system designed to enhance fluid transfer through the skin, by increasing sweat rate, to treat fluid overload in heart failure patients. This study will further evaluate the safety, efficacy, and usability of the AquaPass system in the hospital and home settings. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Chronic Heart Failure, Fluid Overload, Acute Decompensated Heart Failure
- What is being tested?
- AquaPass
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to May 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject that was hospitalized with fluid overload and a history of chronic heart failure and CKD stages 1-4
- Subject has composite congestion score ≥3.
- Baseline systolic blood pressure at rest of ≥100mmHg.
- Subject is capable of meeting the following study requirements:
- For patients with BMI <30 kg/m2: baseline NT-pro BNP>1,600 pg/ml
- For patients with BMI >30 kg/m2: baseline NT-pro BNP >800 pg/ml
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- For patients with rate-controlled persistent or permanent AF: NT-pro BNP >2,400 pg/ml.
- Subject successfully completes 2-4 hours of run-in acclimation session
- Minimal sweat rate in the last hour of run-in acclimatization of 130gr/hours
Who cannot join
- Subject is enrolled to another clinical investigation that might interfere with this study.
- Baseline systolic blood pressure <100 mm Hg
- Subject considered to be in the acute worsening of the heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrythmia, infection or other medical condition unrelated to fluid overload.
- Subject has any known lower body skin problems (open wounds, ulcers)
- Subject with severe peripheral arterial disease
- Subject is pregnant or planning to become pregnant within the study period, or lactating mothers.
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- End-stage renal disease (eGFR<15 ml/min/1.73 m2) or requiring dialysis.
- Inability or unwillingness to comply with the study requirements.
- History of heart transplant or actively listed for heart transplant or Left Ventricular Assist Device (LVAD).
- Implanted left ventricular assist device or implant anticipated <3 months.
- Malignancy or other noncardiac condition limiting life expectancy to <12 months.
About this study
Official title: Evaluating the Safety and Efficacy of the AquaPass System a Renal-independent Fluid Removal System in ADHF Patients Suffering From Fluid Overload. a European Registry
The AquaPass is a non-invasive, renal-intended system designed to enhance fluid transfer through the skin, by increasing sweat rate, to treat fluid overload in heart failure patients.
This study will further evaluate the safety, efficacy, and usability of the AquaPass system in the hospital and home settings.
Read the detailed description
The AquaPass system is non-invasive and functions independently of the renal system, targeting the direct removal of fluids directly from the interstitial compartment through the skin, by activating the eccrine sweat glands.
The patient wears a component that is connected to a control unit, which induces warm air to create a controlled environment around the skin, stimulating sweat production. The sweat evaporates instantly, ensuring that the patient remains dry and comfortable.
In this study, the investigators would like to further investigate the efficacy of the system, when used in hospital settings in patients hospitalized for decompensated heart failure and fluid overload, and to continue the treatment in their homes, immediately after the hospitalization, for another 30 days.
- Being tested
- AquaPass
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquaPassDevice
The AquaPass system works by activating the body's natural sweating mechanism to remove excess fluid from the interstitial compartment. This process is achieved by wearing a garment that creates optimal microclimate conditions around the skin.
The system is controlled by a portable unit that delivers warm air to the wearable component while ensuring patient safety.
| Study group | Role | What they receive |
|---|---|---|
| AquaPass | Experimental | Patients hospitalized with chronic heart failure symptoms and fluid overload will be treated in two phases:
Phase 1: 'In Hospital' Phase: Patients will be enrolled in the study when admitted to the hospital with fluid overload.
Use of the AquaPass system will be performed in the hospital, alongside diuretic therapy.
Phase 2: 'At Home' Phase: Upon the investigator's decision at discharge, the patients will be enrolled in this phase of the study, and will receive AquaPass treatment sessions at their home. Receives: Device: AquaPass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Sweat Rate Per Hour per patient
An average sweat rate of 150 ml/hr per patient at hospital and at home
Measured: 30 days
Incidence of device- and procedure-related side-effects
Incidences of system and treatment-related AEs and SAEs including symptomatic changes in vital signs
Measured: 30 days
Secondary outcomes (7)
Incidence of worsening renal function
Incidence of worsening renal function, measured as an increase of Creatinine levels by >0.5mg/dL
Measured: 30 days
Fluid Overload Related Hospitalizations
Hospitalization or ED visit for decompensated heart failure
Measured: 30 days
Changes in congestion score
to evaluate the effect of the AquaPass treatment on congestion score
Measured: 30 days
Changes in Diuretics Dose
Documentation of changes in diuretics administration to assess safety and potential benefits with system use.
Measured: 30 days
Change of quality of life
Assessment of the quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The minimal score is zero '0' and the highest is '100' when higher scores represent a better outcome for the patient.
Measured: 30 days
Changes in NT-ProBNP levels
Changes in NT-ProBNP levels to demonstrate the system's safety and clinical performance
Measured: 30 days
Change in body weight
To evaluate the effectiveness of the AquaPass System. During the study patients will weighed before and after each treatment. The weight before the first treatment and the weight after the last treatment will be used to assess the treatment performance
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study startFeb 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AquaPass Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401109
- Sponsor's protocol ID
- AQP-CLP-044
- Acronym
- REFORM-HF II
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Efficacy of the AquaPass System a Renal-independent Fluid Removal System in ADHF Patients Suffering From Fluid Overload. a European Registry
- ClinicalTrials.gov ID
- NCT06401109
- Acronym / sponsor ID
- REFORM-HF II / AQP-CLP-044
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AquaPass Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 6 May 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 AquaPass is a non-invasive, renal-intended system designed to enhance fluid transfer through the skin, by increasing sweat rate, to treat fluid overload in heart failure patients.
This study will further evaluate the safety, efficacy, and usability of the AquaPass system in the hospital and home settings.
Detailed description
The AquaPass system is non-invasive and functions independently of the renal system, targeting the direct removal of fluids directly from the interstitial compartment through the skin, by activating the eccrine sweat glands.
The patient wears a component that is connected to a control unit, which induces warm air to create a controlled environment around the skin, stimulating sweat production. The sweat evaporates instantly, ensuring that the patient remains dry and comfortable.
In this study, the investigators would like to further investigate the efficacy of the system, when used in hospital settings in patients hospitalized for decompensated heart failure and fluid overload, and to continue the treatment in their homes, immediately after the hospitalization, for another 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AquaPass | Experimental | Device: AquaPassPatients hospitalized with chronic heart failure symptoms and fluid overload will be treated in two phases: Phase 1: 'In Hospital' Phase: Patients will be enrolled in the study when admitted to the hospital with fluid overload. Use of the AquaPass system will be performed in the hospital, alongside diuretic therapy. Phase 2: 'At Home' Phase: Upon the investigator's decision at discharge, the patients will be enrolled in this phase of the study, and will receive AquaPass treatment sessions at their home. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject that was hospitalized with fluid overload and a history of chronic heart failure and CKD stages 1-4
- Subject has composite congestion score ≥3.
- Baseline systolic blood pressure at rest of ≥100mmHg.
- Subject is capable of meeting the following study requirements:
- For patients with BMI <30 kg/m2: baseline NT-pro BNP>1,600 pg/ml
Key exclusion criteria (11 listed)
- Subject is enrolled to another clinical investigation that might interfere with this study.
- Baseline systolic blood pressure <100 mm Hg
- Subject considered to be in the acute worsening of the heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrythmia, infection or other medical condition unrelated to fluid overload.
- Subject has any known lower body skin problems (open wounds, ulcers)
- Subject with severe peripheral arterial disease
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 |
|---|---|---|
| AquaPassThe AquaPass system works by activating the body's natural sweating mechanism to remove excess fluid from the interstitial compartment. This process is achieved by wearing a garment that creates optimal microclimate conditions around the skin. The system is controlled by a portable unit that delivers warm air to the wearable component while ensuring patient safety. | Device | AquaPass |
Primary outcome
Average Sweat Rate Per Hour per patient
Time frame: 30 days
An average sweat rate of 150 ml/hr per patient at hospital and at home
Incidence of device- and procedure-related side-effects
Time frame: 30 days
Incidences of system and treatment-related AEs and SAEs including symptomatic changes in vital signs
7 secondary outcomes
Incidence of worsening renal function
Time frame: 30 days
Fluid Overload Related Hospitalizations
Time frame: 30 days
Changes in congestion score
Time frame: 30 days
Changes in Diuretics Dose
Time frame: 30 days
Change of quality of life
Time frame: 30 days
Changes in NT-ProBNP levels
Time frame: 30 days
Change in body weight
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing AquaPass in people with Chronic Heart Failure and Fluid Overload, run by AquaPass Medical Ltd..
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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Average Sweat Rate Per Hour per patient (time frame: 30 days). 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 6 May 2024.