Back to resultsAquaPass Device in Treatment of CHF Patients
Primary Purpose
Chronic Heart Failure, Edema, CHF
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
The AquaPass System
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure
Eligibility Criteria
Inclusion Criteria: 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: 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. Exclusion Criteria: 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. 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.
Sites / Locations
- Rambam Health Care CampusRecruiting
- Rabin medical center, campus BelinsonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients are hospitalized with chronic heart failure symptoms and fluid overloaded
Arm Description
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.
Outcomes
Primary Outcome Measures
Average fluid loss from sweat ≥ 500 mL per treatment of 4 hours at least
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
Fluid loss from sweat will be measures after each procedure.
Change of diuretic therapy (quantified by daily equivalent dose of furosemide)
Concomitant medications will be monitored.
Change of congestion score.
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.
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).
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)
Lab tests will be taken.
Change of serum creatinine.
Lab tests will be taken.
Hospitalization or Emergency Room (ER) visit for heart failure
Patient will be followed and monitored.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05843201
Brief Title
AquaPass Device in Treatment of CHF Patients
Official Title
Evaluation of Safety, Performance, and Usability of the AquaPass Device in Treatment of CHF Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 23, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AquaPass Medical Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Edema, CHF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients are hospitalized with chronic heart failure symptoms and fluid overloaded
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
The AquaPass System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average fluid loss from sweat ≥ 500 mL per treatment of 4 hours at least
Description
Fluid loss from sweat will be measures after each procedure
Time Frame
Up to 60 days
Secondary Outcome Measure Information:
Title
Average fluid loss from sweat ≥ 500 mL per treatment of 4 hours at least
Description
Fluid loss from sweat will be measures after each procedure.
Time Frame
Up to 60 days
Title
Change of diuretic therapy (quantified by daily equivalent dose of furosemide)
Description
Concomitant medications will be monitored.
Time Frame
Up to 60 days
Title
Change of congestion score.
Description
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.
Time Frame
Up to 60 days
Title
Change of body weight.
Description
Patient body weight will be measure pre and post procedure
Time Frame
Up to 60 days following hospital discharge
Title
Change of quality of life as assessed by the Kansas City Cardiac Questionnaire-12 (The KCCQ-12).
Description
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
Time Frame
Up to 60 days
Title
Change of N-terminal pro b-type natriuretic peptide (NT-proBNP)
Description
Lab tests will be taken.
Time Frame
Up to 60 days
Title
Change of serum creatinine.
Description
Lab tests will be taken.
Time Frame
Up to 60 days
Title
Hospitalization or Emergency Room (ER) visit for heart failure
Description
Patient will be followed and monitored.
Time Frame
Up to 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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:
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gali Vino
Phone
+972525527565
Email
gali@aquapass-medical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yaakov Nitzan
Phone
972-548005493
Email
yaacov@aquapass-medical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doron Aronson, Prof.
Organizational Affiliation
Rambam MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doron Aronson, Professor
Phone
+972-4-7772180
Email
d_aronson@rmc.gov.il
First Name & Middle Initial & Last Name & Degree
Doron Aronson
Facility Name
Rabin medical center, campus Belinson
City
Petah tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuvia Ben-Gal
Email
bengalt@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Tuvia Ben-Gal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
AquaPass Device in Treatment of CHF Patients
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