ASN's Mission

To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on X

Kidney Week

Abstract: TH-PO1293

Reducing Fluid Overload in Cardiorenal Syndrome by Enhancing Insensible Fluid Loss: The REFORM-HF Trial

Session Information

Category: Cardiovascular-Kidney-Metabolic Health

  • 602 Cardiovascular-Kidney-Metabolic Health: Clinical

Authors

  • Ben Gal, Tuvia, Rabin Medical Center, Petah Tikva, Israel
  • Aronson, Doron, Rambam Health Care Campus, Haifa, Haifa District, Israel
  • Stoner, Benjamin, Cone Health, Greensboro, North Carolina, United States
  • Alexy, Tamas, Regents of the University of Minnesota, Minneapolis, Minnesota, United States
  • Bhatt, Kunjan, Austin Heart Hospital, Austin, Texas, United States
  • Klein, Liviu, University of California San Francisco, San Francisco, California, United States
  • Abraham, William, The Ohio State University, Columbus, Ohio, United States
  • Feitell, Scott, Rochester General Hospital, Rochester, New York, United States
Background


Volume overload and congestion are particularly difficult to manage in patients with heart failure and the cardiorenal syndrome (CRS). In these patients, diuretic resistance is common, and decongestion is often incomplete. Because excess fluid is largely interstitial, the skin offers a massive surface area to remove sodium and water directly from the interstitial compartment.

Methods


The ECCON System enhances fluid and salt loss via the eccrine sweat glands, thereby augmenting insensible fluid losses (IFL). The device activates eccrine sweat glands by increasing skin temperature to 35°C–40°C, where the relationship between temperature and sweat production is linear.
This is a pre-specified mechanistic analysis of REFORM-HF, a prospective, multicenter, single-arm, within-subject controlled trial, conducted at 11 centers in the US and Israel. Major inclusion criteria include: NYHA Class II or III, renal dysfunction (CKD stageII-IV), and persistent or worsening congestion despite a daily dose of ≥80 mg furosemide.
The study utilized a 4-day protocol: Day 1, the control phase, where subjects are observed under their usual care; Day 2 - demonstrating the treatment method; Days 3 and 4 are the active treatment days, with device therapy administered for ~5 hours. IFL is calculated via mass balance body weight change that remains unaccounted for by the net balance of fluid and solid intake and output.

Results


The REFORM-HF trial recruited 33 patients. The median IFL (treatment vs. Control) was 1.15 L per treatment session [IQR 1.15 to 1.30]. Quantile regression demonstrated no significant relationship between eGFR and the ECCON system performance across CKD stages as shown in the Figure. There were 3 worsening renal function events (all transient) and no dyskalemia events related to the procedure.

Conclusion


The ECCON system is a renal-independent approach that achieves clinically meaningful fluid removal rates. This trial supports the concept of enhancing IFL to bypass renal dysfunction and overcome diuretic resistance in the CRS.

Funding

  • Commercial Support – AquaPass