Chronic Heart FailureNCT05843201
AquaPass Device in Treatment of CHF Patients
A study testing The AquaPass System in people with Chronic Heart Failure and Edema, run by AquaPass Medical Ltd. at 2 sites in Israel.
Trial summary
The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients. This study will examine safety, performance and usability of the AquaPass device in two phases: Phase 1: Hospitalization treatment. Phase 2: Home/outpatient clinic treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Edema, CHF
- What is being tested?
- The AquaPass System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesIsrael
- Study dates
- 20 Feb 2022to 12 Dec 2023
- 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
- Age ≥ 18
- Subject was hospitalized for worsening of chronic heart failure with fluid overload.
- Recruitment with expectation for at least 2 additional days in hospital.
- Subject has composite congestion score ≥3.
- Baseline systolic blood pressure ≥100.
- Subject is capable of meeting the following study requirements:
Show all 15Show fewer
- Subject is taking a standing diuretic dose of ≥40 mg/day
- For patients with BMI <30 kg/m2: baseline N-terminal pro b-type natriuretic peptide (NT-proBNP)>1,600 pg/ml
- For patients with BMI >30 kg/m2: baseline N-terminal pro b-type natriuretic peptide (NT-proBNP) >800 pg/ml
- For patients with rate-controlled persistent or permanent Atrial Fibrillation (AF): N-terminal pro b-type natriuretic peptide (NT-proBNP) >2,400 pg/ml.
- Subject completes 2 hours of run-in acclimatization session as follows:
- Put on the wearable and see if the patient fits inside it comfortably.
- Turn on console and see if the patient feels well when the skin temperatures are at least 37°C.
- Blood Pressure, Heart Rate, Core Temperature and have not changed, relative to baseline, by more than 20%.
- Systolic BP does not drop below 90 mmHg in 2 consecutive measurements.
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.
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Rambam Health Care Campus
Haifa, 3109601
Rabin medical center, campus Belinson
Petah Tikva
About this study
Official title: Evaluation of Safety, Performance, and Usability of the AquaPass Device in Treatment of CHF Patients
The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients.
This study will examine safety, performance and usability of the AquaPass device in two phases:
Phase 1: Hospitalization treatment. Phase 2: Home/outpatient clinic treatment
Read the detailed description
The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients.
This study will examine safety, performance and usability of the AquaPass device in two phases:
Phase 1: Hospitalization treatment: This phase will begin when the patients are hospitalized with chronic heart failure symptoms and fluid overloaded and undergo sequential treatments. This phase will be conducted using a prospective case-control design, with measuring endpoint during hospitalization and follow-up (after discharge).
Phase 2: Home treatment: Upon investigator decision at discharge, patients will use Aqua-Pass device at home or at outpatient, after discharge, aiming to refine fluid management and prevent re-admission. This phase will require a separate Informed Consent Form (ICF) and will be conducted using a prospective single-group pre-post design.
- A multi-center, prospective, open label, one arm study.
- Chronic heart failure patients will be enrolled into the study when admitted to the hospital with fluid overload.
- During the in-hospitalization treatment phase, patients will undergo up to 5 procedures with the Aqua-Pass device between 3-8 hours.
- Following discharge and upon investigator decision, patients will sign a dedicated ICF and continue the Aqua-Pass treatments at home or in the outpatient clinic for up to 60 days, at a rate of 1-4 treatments per week.
- Follow up assessments, either during visit or over the phone, 7±2 days from the last procedure
- Conditions
- Chronic Heart Failure, Edema, CHF
- Being tested
- The AquaPass System
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The AquaPass SystemDevice
The system is a non-invasive, multiple use device intended for use at the hospital, at the outpatient clinic settings or at home. The system administers warm, dry air around the patients' body in order to create environmental conditions that increase the patients' sweat rate. Throughout the treatment, fluids from the interstitial compartment are removed from the body by the eccrine sweat glands.
| Study group | Role | What they receive |
|---|---|---|
| Patients are hospitalized with chronic heart failure symptoms and fluid overloaded | Experimental | Phase 1: 'In Hospital' Phase: chronic heart failure (CHF) patients are enrolled in the study when admitted to the hospital with fluid overload.
Study procedures performed, alongside diuretic therapy, in the hospital. Phase 2: 'At Home' Phase: Upon investigator's decision at discharge, the patients are enrolled in the second phase of the study for additional treatment sessions at home. Receives: Device: The AquaPass System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of in-hospital procedures with fluid loss from sweat of >500 ml/session
The primary performance endpoint for the in-hospital phase is the amount of fluid loss from sweat per treatment procedure (~4h); the target rate of sweat production is >500 ml/session in the in-hospital phase.
Measured: In-Hospital Phase [2-10 days]
Incidences of Device and treatment-related AEs and SAEs and symptomatic changes in vital signs
Symptomatic changes in vital signs including incidences of symptomatic hypotension and a decrease of more than 50% in eGFR compared to baseline
Measured: up to 70 days
Secondary outcomes (6)
Change in body weight
To assess the effectiveness of the AquaPass System during the treatment phase patients will be assessed for their weight prior to the first treatment and after the last treatment
Measured: Up to 60 days
Change of diuretic therapy
Documentation of changes in diuretics administration to assess safety and potential benefits with system use. (quantified by daily equivalent dose of furosemide).
Measured: Up to 60 days
Changes in NT-ProBNP levels
Changes in NT-ProBNP levels to demonstrate the system's safety and performance
Measured: Up to 60 days
Rate of Hospitalizations or emergency visits for decompensated heart failure
Documentation of CHF-related hospitalizations to assess safety and potential benefits with system use
Measured: Up to 60 days
Changes in Renal function
Changes in blood electrolytes that are correlated with worsening of renal function
Measured: up to 60 days
Change of quality of life as assessed by the KCCQ-12
Patients will be asked to complete the KCCQ-12 Questionnaire to evaluate their QoL during the study and assess the potential effect of the treatment on their well-being
Measured: Up to 60 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 2023
- Study start20 Feb 2022
- Primary completion14 Aug 2023
- Study completion12 Dec 2023
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 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AquaPass Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doron Aronson, Prof., Principal investigator, Rambam MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843201
- Sponsor's protocol ID
- AQP-009
- Status last verified
- Nov 2023
- First submitted
- 2 Mar 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aronson D, Nitzan Y, Petcherski S, Shaul A, Abraham WT, Burkhoff D, Ben Gal T. Enhancing Sweat Rate for In-Hospital and Home-Based Decongestive Therapy. J Card Fail. 2026 Jan;32(1):5-12. doi: 10.1016/j.cardfail.2025.01.010. Epub 2025 Jan 29.
PubMed 39890012
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety, Performance, and Usability of the AquaPass Device in Treatment of CHF Patients
- ClinicalTrials.gov ID
- NCT05843201
- Acronym / sponsor ID
- AQP-009
- Conditions
- Chronic Heart Failure, Edema, CHF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AquaPass Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 6 May 2023 (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 System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients.
This study will examine safety, performance and usability of the AquaPass device in two phases:
Phase 1: Hospitalization treatment. Phase 2: Home/outpatient clinic treatment
Detailed description
The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients.
This study will examine safety, performance and usability of the AquaPass device in two phases:
Phase 1: Hospitalization treatment: This phase will begin when the patients are hospitalized with chronic heart failure symptoms and fluid overloaded and undergo sequential treatments. This phase will be conducted using a prospective case-control design, with measuring endpoint during hospitalization and follow-up (after discharge).
Phase 2: Home treatment: Upon investigator decision at discharge, patients will use Aqua-Pass device at home or at outpatient, after discharge, aiming to refine fluid management and prevent re-admission. This phase will require a separate Informed Consent Form (ICF) and will be conducted using a prospective single-group pre-post design.
- A multi-center, prospective, open label, one arm study.
- Chronic heart failure patients will be enrolled into the study when admitted to the hospital with fluid overload.
- During the in-hospitalization treatment phase, patients will undergo up to 5 procedures with the Aqua-Pass device between 3-8 hours.
- Following discharge and upon investigator decision, patients will sign a dedicated ICF and continue the Aqua-Pass treatments at home or in the outpatient clinic for up to 60 days, at a rate of 1-4 treatments per week.
- Follow up assessments, either during visit or over the phone, 7±2 days from the last procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients are hospitalized with chronic heart failure symptoms and fluid overloaded | Experimental | Device: The AquaPass SystemPhase 1: 'In Hospital' Phase: chronic heart failure (CHF) patients are enrolled in the study when admitted to the hospital with fluid overload. Study procedures performed, alongside diuretic therapy, in the hospital. Phase 2: 'At Home' Phase: Upon investigator's decision at discharge, the patients are enrolled in the second phase of the study for additional treatment sessions at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18
- Subject was hospitalized for worsening of chronic heart failure with fluid overload.
- Recruitment with expectation for at least 2 additional days in hospital.
- Subject has composite congestion score ≥3.
- Baseline systolic blood pressure ≥100.
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 |
|---|---|---|
| The AquaPass SystemThe system is a non-invasive, multiple use device intended for use at the hospital, at the outpatient clinic settings or at home. The system administers warm, dry air around the patients' body in order to create environmental conditions that increase the patients' sweat rate. Throughout the treatment, fluids from the interstitial compartment are removed from the body by the eccrine sweat glands. | Device | Patients are hospitalized with chronic heart failure symptoms and fluid overloaded |
Primary outcome
Rate of in-hospital procedures with fluid loss from sweat of >500 ml/session
Time frame: In-Hospital Phase [2-10 days]
The primary performance endpoint for the in-hospital phase is the amount of fluid loss from sweat per treatment procedure (~4h); the target rate of sweat production is >500 ml/session in the in-hospital phase.
Incidences of Device and treatment-related AEs and SAEs and symptomatic changes in vital signs
Time frame: up to 70 days
Symptomatic changes in vital signs including incidences of symptomatic hypotension and a decrease of more than 50% in eGFR compared to baseline
6 secondary outcomes
Change in body weight
Time frame: Up to 60 days
Change of diuretic therapy
Time frame: Up to 60 days
Changes in NT-ProBNP levels
Time frame: Up to 60 days
Rate of Hospitalizations or emergency visits for decompensated heart failure
Time frame: Up to 60 days
Changes in Renal function
Time frame: up to 60 days
Change of quality of life as assessed by the KCCQ-12
Time frame: Up to 60 days
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 12 Dec 2024.
- Derived from this study: PubMed 39890012Aronson D, Nitzan Y, Petcherski S, Shaul A, Abraham WT, Burkhoff D, Ben Gal T. Enhancing Sweat Rate for In-Hospital and Home-Based Decongestive Therapy. J Card Fail. 2026 Jan;32(1):5-12. doi: 10.1016/j.cardfail.2025.01.010. Epub 2025 Jan 29.
- Individual participant dataSharing planned: No
Related trials for Chronic Heart Failure
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
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.
Doron Aronson, Prof. principal investigator
Rambam MC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The AquaPass System in people with Chronic Heart Failure and Edema, run by AquaPass Medical Ltd. at 2 sites in Israel.
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 15 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: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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?
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?
Rate of in-hospital procedures with fluid loss from sweat of >500 ml/session (time frame: In-Hospital Phase [2-10 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?
On the ClinicalTrials.gov record for NCT05843201, 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 12 Dec 2024.