Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients, a European Registry

Launched by AQUAPASS MEDICAL LTD. · May 3, 2024

Keywords

ClinConnect Summary

The clinical trial titled "Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients" is studying a new device called AquaPass. This device is designed to help patients with heart failure who are experiencing fluid overload, a condition where the body holds onto too much fluid, leading to swelling and discomfort. The AquaPass works by promoting sweating to help remove excess fluid from the body, which may improve symptoms and overall health. The trial will assess how safe and effective this device is for patients, both in hospitals and at home.

To participate in this study, individuals should be hospitalized due to fluid overload and have a history of chronic heart failure. They need to meet specific health criteria, such as having a certain level of a blood marker called NT-pro BNP, which indicates heart stress. Additionally, participants must be able to tolerate a 2-4 hour acclimation session with the device. It's important to note that individuals with certain health issues, like severe heart problems or skin conditions, may not be eligible. Those who join the study can expect to use the AquaPass and provide feedback on their experience, helping researchers understand how well it works for managing fluid overload in heart failure patients.

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ALL

Eligibility criteria

• 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 actively listed for heart transplant or Left Ventricular Assist Device (LVAD).
• • Implanted left ventricular assist device or implant anticipated \<3 months.
• • Malignancy or other noncardiac condition limiting life expectancy to \<12 months.