Rochester, NYNCT06360380Now EnrollingIRB Ready

Chronic Heart Failure Clinical Trial in Rochester, NY

Access cutting-edge chronic heart failure treatment through this clinical trial at a research site in Rochester. Study-provided care at no cost to qualified participants.

Sponsored by AquaPass Medical Ltd.

Quick Self-Assessment

See if you qualify for this Rochester location

Preparing your pre-screening questions…

Expert Care in Rochester

Access chronic heart failure specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related chronic heart failure treatment provided free

Apply for This Rochester Location

Check if you qualify for this chronic heart failure clinical trial in Rochester, NY

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Rochester

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Rochester site if eligible
  4. 4Begin participation

About This Chronic Heart Failure Study in Rochester

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.

Sponsor: AquaPass Medical Ltd.

Who Can Participate

Inclusion 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 responding adequately or are resistant to current medical treatment as evidenced by persistent or worsening congestion, despite a daily dose of 80 mg furosemide or greater or the equivalent dose of another loop diuretic .
No change in diuretic dosage in the past 5 days
Subjects 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

Exclusion Criteria

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, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload .
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
Subjects 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
Subjects 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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT06360380) has an active research site in Rochester, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Heart Failure Treatment Options in Rochester, NY

If you're searching for chronic heart failure treatment options in Rochester, NY, this clinical trial (NCT06360380) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic heart failure specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic heart failure clinical trials near you to find additional studies recruiting in your area.

More Heart Failure Trials in Rochester, NY

See all heart failure clinical trials recruiting in Rochester — not just this study.

Browse Heart Failure Trials in Rochester →

Browse More Trials by Condition

Heart Failure TrialsInterstitial Cystitis TrialsFanconi Anemia TrialsAll Conditions →

Ready to Join in Rochester?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Rochester, NY