Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients, a European Reg… (NCT06401109) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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 range21 Years – 80 Years
SexALL
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…
What they're measuring
1
Average Sweat Rate Per Hour per patient
Timeframe: 30 days
2
Incidence of device- and procedure-related side-effects