RECRUITING

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

Conditions

Chronic Heart Failure CKD Stage 3 Aquapass Sweat Enhancement Fluid removal CHF

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

REFORM-HF™ Reducing Fluid Overload Using Renal Independent SysteM in Heart Failure Patients

Quick Facts

Study Start:2024-09-05

Study Completion:2025-01-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06360380

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥21 years and \< 80 years * Patient, with known decompensated heart failure and/or CKD stage 2 or more presenting with fluid overload, defined by a congestion score of ≥3, who are not responding adequately or are resistant to current medical treatment as evidenced by persistent or worsening congestion, despite a daily dose of 40 mg furosemide or greater or the equivalent dose of another loop diuretic. * Patients with no Heart Failure related hospitalization in the past 30 days * No change in diuretic regimen in the past 7 days * Baseline NT-proBNP ≥600 pg/mL * Baseline systolic blood pressure ≥100 mmHg * Patient is able and willing to provide written informed consent, inclusive of the release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation * Patient is not participating in any clinical investigation that may interfere with the data collection or the results of this study	* Patient considered to be in the acute worsening of heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload. * Patient has any known or visible lower body (non-facial) skin problems (open wounds, ulcers, infections) * Patient with severe peripheral arterial disease * Patient is pregnant or planning to become pregnant within the study period, or a lactating woman. * Renal disease with eGFR \<25 ml/min/1.73 m2 * Patients with known hypothalamic disorders * Patients with known hypohidrosis disorders * Patients with medical technology dependency (gastric (G) tubes, ventilators etc.) * Patients with cystic fibrosis * Patients with active infections * Inability or unwillingness to comply with the study requirements * Patients with unstable electrolytes or acid-base balance (per investigator's discretion) * Known Severe aortic valve or mitral valve stenosis * History of a heart transplant or actively listed for a heart transplant or LVAD * Implanted left ventricular assist device or implant anticipated \<3 months * Patients with an active, malignant disease and whose life expectancy is \< 6 months (per investigator's discretion) * Unstable or acutely worsening cardiac or renal conditions (per investigator's discretion)

Inclusion Criteria

Exclusion Criteria

* Age ≥21 years and \< 80 years
* Patient, with known decompensated heart failure and/or CKD stage 2 or more presenting with fluid overload, defined by a congestion score of ≥3, who are not responding adequately or are resistant to current medical treatment as evidenced by persistent or worsening congestion, despite a daily dose of 40 mg furosemide or greater or the equivalent dose of another loop diuretic.
* Patients with no Heart Failure related hospitalization in the past 30 days
* No change in diuretic regimen in the past 7 days
* Baseline NT-proBNP ≥600 pg/mL
* Baseline systolic blood pressure ≥100 mmHg
* Patient is able and willing to provide written informed consent, inclusive of the release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation
* Patient is not participating in any clinical investigation that may interfere with the data collection or the results of this study

* Patient considered to be in the acute worsening of heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload.
* Patient has any known or visible lower body (non-facial) skin problems (open wounds, ulcers, infections)
* Patient with severe peripheral arterial disease
* Patient is pregnant or planning to become pregnant within the study period, or a lactating woman.
* Renal disease with eGFR \<25 ml/min/1.73 m2
* Patients with known hypothalamic disorders
* Patients with known hypohidrosis disorders
* Patients with medical technology dependency (gastric (G) tubes, ventilators etc.)
* Patients with cystic fibrosis
* Patients with active infections
* Inability or unwillingness to comply with the study requirements
* Patients with unstable electrolytes or acid-base balance (per investigator's discretion)
* Known Severe aortic valve or mitral valve stenosis
* History of a heart transplant or actively listed for a heart transplant or LVAD
* Implanted left ventricular assist device or implant anticipated \<3 months
* Patients with an active, malignant disease and whose life expectancy is \< 6 months (per investigator's discretion)
* Unstable or acutely worsening cardiac or renal conditions (per investigator's discretion)

Contacts and Locations

Study Contact

Scott C Feitell, DO

CONTACT

(585) 442 5320

scott.feitell@rochesterregional.org

Principal Investigator

Scott C Feitell, DO

PRINCIPAL_INVESTIGATOR

Rochester Regional Health

Study Locations (Sites)

Rochester Regional Health

Rochester, New York, 14621

United States

Cone Health Advanced Heart Failure Clinic at Moses Cone

Greensboro, North Carolina, 27401

United States

Collaborators and Investigators

Sponsor: AquaPass Medical Ltd.

Scott C Feitell, DO, PRINCIPAL_INVESTIGATOR, Rochester Regional Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-05

Study Completion Date2025-01-29

Study Record Updates

Study Start Date2024-09-05

Study Completion Date2025-01-29

Terms related to this study

Keywords Provided by Researchers

Aquapass
Sweat Enhancement
Fluid removal
CHF

Additional Relevant MeSH Terms

Chronic Heart Failure
CKD Stage 3