Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients, a European Reg… (NCT06401109) | Clinical Trial Compass
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Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients, a European Registry
30 participantsStarted 2025-02
Plain-language summary
The AquaPass is a non-invasive, renal-intended system designed to enhance fluid transfer through the skin, by increasing sweat rate, to treat fluid overload in heart failure patients.
This study will further evaluate the safety, efficacy, and usability of the AquaPass system in the hospital and home settings.
Who can participate
Age range
21 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject that was hospitalized with fluid overload and a history of chronic heart failure and CKD stages 1-4
* Subject has composite congestion score ≥3.
* Baseline systolic blood pressure at rest of ≥100mmHg.
* Subject is capable of meeting the following study requirements:
* For patients with BMI \<30 kg/m2: baseline NT-pro BNP\>1,600 pg/ml
* For patients with BMI \>30 kg/m2: baseline NT-pro BNP \>800 pg/ml
* For patients with rate-controlled persistent or permanent AF: NT-pro BNP \>2,400 pg/ml.
* Subject successfully completes 2-4 hours of run-in acclimation session
* Minimal sweat rate in the last hour of run-in acclimatization of 130gr/hours
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average Sweat Rate Per Hour per patient
Timeframe: 30 days
2
Incidence of device- and procedure-related side-effects