Sweat-Powered relief: could a High-Tech suit drain fluid from heart failure patients?
NCT ID NCT06360380
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This study tests a wearable suit called AquaPass that removes excess fluid through sweat in people with chronic heart failure and fluid overload. Participants wear the suit for up to 5 hours in a hospital or clinic, alongside their usual medications. The goal is to see if the suit can safely remove at least 500 mL of extra fluid per session, potentially easing symptoms like swelling and shortness of breath.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AquaPass System (wearable suit that removes fluid through sweat)
- What this could lead to
- If it works, this could offer a new way to manage fluid overload in heart failure patients, reducing reliance on diuretics and improving comfort.
- What could go wrong
- This is an early, small study (40 people) testing feasibility and safety. The device may not remove enough fluid, or could cause side effects like dehydration or skin irritation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥21 years and \< 80 years 2. Subject, with known decompensated heart failure NYHA Class II, III (as evaluated by an independent observer who is not on the study team) presenting with fluid overload, defined by a congestion score of ≥3, who are not responding adequately or are resistant to current medical treatment as evidenced by persistent or worsening congestion, despite a daily dose of 80 mg furosemide or greater or the equivalent dose of another loop diuretic . 3. No change in diuretic dosage in the past 5 days 4. Subjects with eGFR between 15-89 mL/min/1.73m2 5. Baseline NT-proBNP ≥600 pg/mL 6. Baseline systolic blood pressure ≥100 mmHg 7. Subject is able and willing to provide written informed consent, inclusive of the release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation 8. Subject is not participating in any clinical investigation that may interfere with the data collection or the results of this study Exclusion Criteria: 1. Subject considered to be in the acute worsening of heart failure: Requiring invasive or non-invasive mechanical ventilation, mechanical circulatory support or is clinically unstable requiring pressors, inotropes, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload . 2. Subject has any known or visible lower body (non-facial) skin condition (open wounds, ulcers, infections) that can potentially prevent using the wearable for the duration of the procedure 3. Known allergy to Polyester or Thermoplastic polyurethane (TPU) 4. Subject with severe peripheral arterial disease 5. Subject is pregnant or planning to become pregnant within the study period, or a lactating woman. 6. Subject with known hypothalamic disorders 7. Subject with known hypohidrosis disorders 8. Subjects with external medical technology dependency (gastric (G) tubes, ventilators, peripherally inserted central venous catheters, etc.) 9. Subject with cystic fibrosis 10. Subject with active infections 11. Inability or unwillingness to comply with the study requirements 12. Subjects with unstable electrolytes or acid-base balance (as per investigator's discretion) 13. Known Severe aortic valve or mitral valve stenosis 14. History of a heart transplant or actively listed for a heart transplant 15. Implanted left ventricular assist device (LVAD) or implant anticipated in \<3 months 16. Subject with a life expectancy of less than 6 months, per investigator's discretion, due to malignant or non-cardiac comorbidities
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Austin Heart Hospital
RECRUITINGAustin, Texas, 78705, United States
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Cone Health Advanced Heart Failure Clinic at Moses Cone
RECRUITINGGreensboro, North Carolina, 27401, United States
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Mission Hospital
RECRUITINGAsheville, North Carolina, 28801, United States
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Northwell Health- Lenox Hill Hospital
RECRUITINGNew York, New York, 10075, United States
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Rabin Medical Center
RECRUITINGPetah Tikva, 49100, Israel
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Rambam Medical Campus
RECRUITINGHaifa, 3109601, Israel
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Rochester Regional Health
RECRUITINGRochester, New York, 14621, United States
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UC San Diego Health-Sulpizio Cardiovascular Center
RECRUITINGLa Jolla, California, 92037, United States
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UC San Francisco
RECRUITINGSan Francisco, California, 94143, United States
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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55455, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A gentle electric pulse to the heart: new device tested for heart failure
- Can a heart drug shield the brain? a trial investigates Vericiguat's potential to slow cognitive decline
- Fine-Tuning heart failure drugs to flush out excess salt
- A supplement that could help heart failure patients shed excess fluid?
- Can a wearable predict heart failure Flare-Ups before they happen?