Sweat-Powered relief: could a High-Tech suit drain fluid from heart failure patients?

NCT ID NCT06360380

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

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

21 to 79 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    10 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Austin Heart Hospital

    RECRUITING

    Austin, Texas, 78705, United States

  • Cone Health Advanced Heart Failure Clinic at Moses Cone

    RECRUITING

    Greensboro, North Carolina, 27401, United States

  • Mission Hospital

    RECRUITING

    Asheville, North Carolina, 28801, United States

  • Northwell Health- Lenox Hill Hospital

    RECRUITING

    New York, New York, 10075, United States

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, 49100, Israel

  • Rambam Medical Campus

    RECRUITING

    Haifa, 3109601, Israel

  • Rochester Regional Health

    RECRUITING

    Rochester, New York, 14621, United States

  • UC San Diego Health-Sulpizio Cardiovascular Center

    RECRUITING

    La Jolla, California, 92037, United States

  • UC San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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