Phase
Condition
Congestive Heart Failure
Hyponatremia
Heart Failure
Treatment
The AquaPass System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 natriureticpeptide (NT-proBNP)>1,600 pg/ml
For patients with BMI >30 kg/m2: baseline N-terminal pro b-type natriureticpeptide (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 temperaturesare at least 37°C.
Blood Pressure, Heart Rate, Core Temperature and have not changed, relative tobaseline, by more than 20%.
Systolic BP does not drop below 90 mmHg in 2 consecutive measurements.
Exclusion
Exclusion Criteria:
Subject is enrolled to another clinical investigation that might interfere with thisstudy.
Baseline systolic blood pressure <100 mm Hg
Subject considered to be in the acute worsening of the heart failure: Requiringventilation, mechanical support or is clinically unstable requiring pressors,deterioration triggered by arrythmia, infection or other medical condition unrelatedto 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, orlactating 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 LeftVentricular Assist Device (LVAD).
Implanted left ventricular assist device or implant anticipated <3 months.
Malignancy or other noncardiac condition limiting life expectancy to <12 months.
Study Design
Study Description
Connect with a study center
Rambam Health Care Campus
Haifa, 3109601
IsraelSite Not Available
Rabin medical center, campus Belinson
Petah tikva,
IsraelSite Not Available
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