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New treatment option for Chronic Heart Failure
Official title Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
ClinicalTrials.gov ID: NCT06360380
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 79
You may be able to join if
- Age ≥21 years and \< 80 years
- Subject, with known decompensated heart failure NYHA Class II, III (as evaluated by an independent observer who is not on the study team) presenting...
- No change in diuretic dosage in the past 5 days
- people with eGFR between 15-89 mL/min/1.73m2
- Baseline NT-proBNP ≥600 pg/mL
You likely can't join if
- Subject considered to be in the acute worsening of heart failure: Requiring invasive or non-invasive mechanical ventilation, mechanical circulatory...
- Subject has any known or visible lower body (non-facial) skin condition (open wounds, ulcers, infections) that can potentially prevent using the...
- Known allergy to Polyester or Thermoplastic polyurethane (TPU)
- Subject with severe peripheral arterial disease
- Subject is pregnant or planning to become pregnant within the study period, or a lactating woman.
- Subject with known hypothalamic disorders
See the full eligibility criteria
- Age ≥21 years and \< 80 years
- Subject, with known decompensated heart failure NYHA Class II, III (as evaluated by an independent observer who is not on the study team) presenting with fluid overload, defined by a congestion score of ≥3, who are not...
- No change in diuretic dosage in the past 5 days
- people with eGFR between 15-89 mL/min/1.73m2
- Baseline NT-proBNP ≥600 pg/mL
- Baseline systolic blood pressure ≥100 mmHg
- Subject 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
- Subject is not participating in any clinical investigation that may interfere with the data collection or the results of this study
- Subject considered to be in the acute worsening of heart failure: Requiring invasive or non-invasive mechanical ventilation, mechanical circulatory support or is clinically unstable requiring pressors, inotropes...
- Subject has any known or visible lower body (non-facial) skin condition (open wounds, ulcers, infections) that can potentially prevent using the wearable for the duration of the procedure
- Known allergy to Polyester or Thermoplastic polyurethane (TPU)
- Subject with severe peripheral arterial disease
- Subject is pregnant or planning to become pregnant within the study period, or a lactating woman.
- Subject with known hypothalamic disorders
- Subject with known hypohidrosis disorders
- people with external medical technology dependency (gastric (G) tubes, ventilators, peripherally inserted central venous catheters, etc.)
- Subject with cystic fibrosis
- Subject with active infections
- Inability or unwillingness to comply with the study requirements
- people with unstable electrolytes or acid-base balance (as per investigator's discretion)
- Known Severe aortic valve or mitral valve stenosis
- History of a heart transplant or actively listed for a heart transplant
- Implanted left ventricular assist device (LVAD) or implant anticipated in \<3 months
- Subject with a life expectancy of less than 6 months, per investigator's discretion, due to malignant or non-cardiac comorbidities
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- San Francisco, California, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Rochester, New York, United States
- Asheville, North Carolina, United States
- Greensboro, North Carolina, United States
- Austin, Texas, United States
- Haifa, Israel
- Petah Tikva, Israel
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; San Francisco, California, United States; Minneapolis, Minnesota, United States; New York, New York, United States; Rochester, New York, United States; Asheville, North Carolina, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.