Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System

Part of paid clinical trials in La Jolla, California.

Sponsor
AquaPass Medical Ltd.
Study ID
NCT06360380
Status
Recruiting
Apply to this trial

Conditions

  • CKD Stage 3
  • Chronic Heart Failure

Eligibility Criteria

Sex
ALL
Age
21 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • AquaPass System — DEVICE
    a treatment session of up to 5 hours with the AquaPass system, evaluating net fluid removal for efficacy analysis and effect on vital signs for safety analysis

Study Details

The REFORM-HF study aims to test a new technology, AQUAPASS, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure. Patients will wear a lightweight suit that helps remove excess fluids through their sweat. The investigators want to see if the AQUAPASS system can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics. Participants will be treated in the hospital or in the outpatient clinic.

Key Dates

First listed
Apr 11, 2024
Start date
Aug 12, 2024
Status verified
Jul 2026
Primary completion
Aug 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: AquaPass
    An AquaPass treatment session (up to 5-Hrs.) will be administered and supervised by certified study staff
  • No Intervention: Control
    An observation visit, during which data will be collected on fluid intake, fluid output, congestion score, and body weight. These data will serve as a control for the efficacy primary endpoint comparison.

Primary Outcome Measure

AQUAPASS Performance Evaluation [ Time Frame: 5 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
UC San Diego Health-Sulpizio Cardiovascular CenterLa JollaCalifornia92037
Ori Ben-Yehuda, MD
[email protected]
858-246-2413
Ori Ben-Yehuda, MD (PRINCIPAL_INVESTIGATOR)
Nicholas Wettersten, MD (SUB_INVESTIGATOR)
UC San FranciscoSan FranciscoCalifornia94143
Liviu Klein, MD
[email protected]
619-972-4251
Liviu Klein, MD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55455
Tamas Alexy, MD
[email protected]
612-626-1240
Gretchen Peichel, RN-CRC
[email protected]
612-626-6237
Tamas Alexy, MD (PRINCIPAL_INVESTIGATOR)
Northwell Health- Lenox Hill HospitalNew YorkNew York10075
Gerin Stevens, MD
[email protected]
516-562-1428
Virgenmina Lugaro
[email protected]
212-434-6626
Sirish Vullaganti,, MD (SUB_INVESTIGATOR)
Gerin Stevens,, MD (PRINCIPAL_INVESTIGATOR)
Miguel Alvarez,, MD (SUB_INVESTIGATOR)
Rochester Regional HealthRochesterNew York14621
Scott C Feitell, DO
[email protected]
(585) 442 5320
Kara Cristales, RN
[email protected]
Mission HospitalAshevilleNorth Carolina28801
Vinay Thohan, MD
[email protected]
828-412-9149
Vinay Thohan, MD (PRINCIPAL_INVESTIGATOR)
Matthew Riesbeck, MD (SUB_INVESTIGATOR)
Cone Health Advanced Heart Failure Clinic at Moses ConeGreensboroNorth Carolina27401
Benjamin Stoner, MD
[email protected]
Benjamin Stoner, MD (PRINCIPAL_INVESTIGATOR)
Austin Heart HospitalAustinTexas78705
Kunjan Bhatt, MD
[email protected]
512-206-3600
Kunjan Bhatt, MD (PRINCIPAL_INVESTIGATOR)
Jerome Thomas, MD (SUB_INVESTIGATOR)
Laura Calais, APRN (SUB_INVESTIGATOR)
Jennifer Lord, MSN (SUB_INVESTIGATOR)
Brooke Eden, APRN (SUB_INVESTIGATOR)

Find similar trials in La Jolla, CA

By research site
UC San Diego Health-Sulpizio Cardiovascular Center· La Jolla, CAUC San Francisco· San Francisco, CAUniversity of Minnesota· Minneapolis, MNNorthwell Health- Lenox Hill Hospital· New York, NYRochester Regional Health· Rochester, NYMission Hospital· Asheville, NC

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