Last reviewed · How we verify
NCT06360380: REFORM-HF
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
NA trial testing AquaPass System in Chronic Heart Failure in 40 participants. Currently enrolling.
3 January 2025
Quick facts
| Lead sponsor | AquaPass Medical Ltd. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 5 September 2024 |
| Primary completion | 3 January 2025 |
| Estimated completion | 29 January 2025 |
| Sites | 4 locations across United States, Israel |
Drugs / interventions tested
- AquaPass System
Conditions studied
- Chronic Heart Failure — all drugs for Chronic Heart Failure →
- CKD Stage 3 — all drugs for CKD Stage 3 →
Sponsor
AquaPass Medical Ltd.
Who can join
Adults 21 to 80, any sex, with Chronic Heart Failure or CKD Stage 3. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 select if to be treated at their home or in the outpatient clinic.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06360380
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Heart Failure
Currently open trials in the same condition.
- NCT07265349 — A Phase I/II Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure · Phase 1, PHASE2 · recruiting
- NCT07379840 — A Study to Learn More About How Safe Finerenone is and How Well it Works in Adults With Chronic Heart Failure in South K · recruiting
- NCT07325942 — Effectiveness of Low -Versus High -Volume High -Intensity Interval Training in Patients With Chronic Heart Failure · NA · recruiting
- NCT07434193 — Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergo · NA · recruiting
- NCT07405944 — Vericiguat and Reverse Remodeling Indices in Heart Failure · Phase 4 · recruiting
Other AquaPass Medical Ltd. trials
Trials by the same sponsor.
- NCT06358365 — Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients · NA · completed
- NCT05843201 — AquaPass Device in Treatment of CHF Patients · NA · completed
- NCT04578353 — Effect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous Patients · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06360380 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AquaPass Medical Ltd.
- Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06360380.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing