AquaPass Device in Treatment of CHF Patients
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
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A multi-center, prospective, open label, one arm study.
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Chronic heart failure patients will be enrolled into the study when admitted to the hospital with fluid overload.
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During the in-hospitalization treatment phase, patients will undergo up to 5 procedures with the Aqua-Pass device between 3-8 hours.
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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.
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Follow up assessments, either during visit or over the phone, 7±2 days from the last procedure
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients are hospitalized with chronic heart failure symptoms and fluid overloaded Phase 1: Hospitalization treatment: chronic heart failure (CHF) patients are enrolled into the study when admitted to the hospital with fluid overload. Study procedures performed, alongside diuretic therapy, at the hospital. Phase 2: Home treatment: Upon investigator decision at discharge, the patients are enrolled into phase 2 study for additional study procedures at home, aiming to refine fluid management and prevent re-admission. |
Device: The AquaPass System
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.
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Outcome Measures
Primary Outcome Measures
- Average fluid loss from sweat ≥ 500 mL per treatment of 4 hours at least [Up to 60 days]
Fluid loss from sweat will be measures after each procedure
Secondary Outcome Measures
- Average fluid loss from sweat ≥ 500 mL per treatment of 4 hours at least [Up to 60 days]
Fluid loss from sweat will be measures after each procedure.
- Change of diuretic therapy (quantified by daily equivalent dose of furosemide) [Up to 60 days]
Concomitant medications will be monitored.
- Change of congestion score. [Up to 60 days]
The investigator will assess patient's congestion score once a week as follows: Dyspnea Yes No Pitting edema score 0-Absent; 1-Trace; 2-Slight; 3-Moderate; 4-Marked jugular vein distention (JVD) Yes No Rales 0-Absent; 1-Basilar only; 2->1/3 of lung field The lower the score the better is the physical condition.
- Change of body weight. [Up to 60 days following hospital discharge]
Patient body weight will be measure pre and post procedure
- Change of quality of life as assessed by the Kansas City Cardiac Questionnaire-12 (The KCCQ-12). [Up to 60 days]
The patient will be asked to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ )questionnaire. Higher scores mean a better outcome In general scoring will be done as follows: Severely limited 0 Limited quite a bit 25 Moderately limited 50 Slightly limited 75 Did not limit at all 100 Does not apply or did not do for other reasons Missing The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Summary Score represents an integration of the Physical Limitation, Symptom Frequency, Quality of Life and Social Limitation scales. At least one of the four scale scores must be present in order to calculate the summary score. The score is calculated as the average of the available scale scores, as follows: If at least one of KCCQ12-Physical Limitation (PL), KCCQ12-Symptoms Frequency (SF), KCCQ12-Quality of Life (QL) and KCCQ12-Social Limitation (SL) is not missing, then Kansas City Cardiomyopathy Questionnaire (KCCQ12) = Average of non-missing scale scores
- Change of N-terminal pro b-type natriuretic peptide (NT-proBNP) [Up to 60 days]
Lab tests will be taken.
- Change of serum creatinine. [Up to 60 days]
Lab tests will be taken.
- Hospitalization or Emergency Room (ER) visit for heart failure [Up to 60 days]
Patient will be followed and monitored.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18
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Subject was hospitalized for worsening of chronic heart failure with fluid overload.
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Recruitment with expectation for at least 2 additional days in hospital.
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Subject has composite congestion score ≥3.
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Baseline systolic blood pressure ≥100.
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Subject is capable of meeting the following study requirements:
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Subject is taking a standing diuretic dose of ≥40 mg/day
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For patients with BMI <30 kg/m2: baseline N-terminal pro b-type natriuretic peptide (NT-proBNP)>1,600 pg/ml
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For patients with BMI >30 kg/m2: baseline N-terminal pro b-type natriuretic peptide (NT-proBNP) >800 pg/ml
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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:
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Put on the wearable and see if the patient fits inside it comfortably.
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Turn on console and see if the patient feels well when the skin temperatures are at least 37°C.
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Blood Pressure, Heart Rate, Core Temperature and have not changed, relative to baseline, by more than 20%.
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Systolic BP does not drop below 90 mmHg in 2 consecutive measurements.
Exclusion Criteria:
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Subject is enrolled to another clinical investigation that might interfere with this study.
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Baseline systolic blood pressure <100 mm Hg
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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.
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Subject has any known lower body skin problems (open wounds, ulcers)
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Subject with severe peripheral arterial disease
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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.
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Inability or unwillingness to comply with the study requirements.
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History of heart transplant or actively listed for heart transplant or Left Ventricular Assist Device (LVAD).
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Implanted left ventricular assist device or implant anticipated <3 months.
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Malignancy or other noncardiac condition limiting life expectancy to <12 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rambam Health Care Campus | Haifa | Israel | 3109601 | |
| 2 | Rabin medical center, campus Belinson | Petah tikva | Israel |
Sponsors and Collaborators
- AquaPass Medical Ltd.
Investigators
- Principal Investigator: Doron Aronson, Prof., Rambam MC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AQP-009