AquaPass System for Heart Failure

(REFORM-HF Trial)

Recruiting at 4 trial locations

Overseen By Scott C Feitell, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AquaPass Medical Ltd.

Must be taking: Diuretics

Disqualifiers: Acute heart failure, Pregnancy, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 5 days

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called AquaPass, designed to remove excess fluid in people with heart failure. Patients wear a special suit that induces sweating to expel fluid, potentially aiding when regular medicines fall short. The goal is to determine if AquaPass can remove an additional 500mL of fluid. This trial may suit those with heart failure who experience fluid buildup despite taking diuretics (medicines that help the body eliminate excess water) and have not been hospitalized for heart issues in the past month. Participants can choose to receive the treatment at home or in a clinic. As an unphased trial, this study offers a unique opportunity for patients to explore a novel treatment option that could enhance their quality of life.

Do I have to stop taking my current medications for this trial?

The trial does not specify that you need to stop taking your current medications. In fact, it mentions that the AquaPass system will be used alongside your regular medications like diuretics.

What prior data suggests that the AquaPass System is safe for patients with heart failure?

Research shows that the AquaPass system is designed to help remove excess fluids in people with heart failure. Early results suggest the device may be safe. A study on AquaPass examined its safety and usability both in the hospital and at home, indicating researchers are assessing its use without major problems.

While exact numbers on side effects are not available, testing the device outside the hospital suggests it is likely well-tolerated. When a treatment is used outside of hospital care, it often indicates it doesn't cause significant issues for most patients.

In summary, the AquaPass system appears safe and easy to use. However, like any new treatment, it is important to monitor for updates or new findings as research continues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard heart failure treatments, which often involve medications like ACE inhibitors or beta-blockers, the AquaPass System offers a unique approach by using a non-drug intervention that can be administered at home. The system stands out with its focus on fluid management through a supervised session lasting up to five hours, which could potentially help manage heart failure symptoms more effectively. Researchers are excited about the AquaPass System because it provides a new method of care that might enhance quality of life with fewer hospital visits, offering a convenient and potentially more comfortable experience for patients.

What evidence suggests that the AquaPass System is effective for heart failure?

Research has shown that the AquaPass system, which participants in this trial may receive, can help reduce fluid overload in people with heart failure. The system encourages sweating, aiding the body in eliminating extra fluids. Early results suggest that this device can remove up to 500mL of excess fluid during treatment. By targeting fluids directly from body tissues, this method offers an alternative to traditional methods like diuretics, which help the body eliminate excess water. Initial studies have shown promise in improving patients' comfort and quality of life. ^{1 2 3 4 5}

Who Is on the Research Team?

Scott C Feitell, DO

Principal Investigator

Rochester Regional Health

Are You a Good Fit for This Trial?

This trial is for adults aged 21-79 with chronic heart failure or kidney disease, who have fluid buildup despite taking diuretics. They must have a specific blood marker level (NT-proBNP ≥600 pg/mL), stable medication use in the past week, and be able to consent. Those recently hospitalized for heart failure or on conflicting trials can't join.

Inclusion Criteria

I haven't been hospitalized for heart failure in the last 30 days.

I am between 21 and 79 years old.

Baseline NT-proBNP ≥600 pg/mL

Exclusion Criteria

Patients with known hypohidrosis disorders

Unstable or acutely worsening cardiac or renal conditions (per investigator's discretion)

I have cystic fibrosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Control

An observation visit, during which data will be collected on fluid intake, fluid output, congestion score, body weight, and quality of life. These data will serve as a control for the efficacy primary endpoint comparison.

1 day

1 visit (in-person)

Treatment

Participants receive AquaPass treatment sessions to evaluate fluid loss effectiveness, with daily blood and urine tests to monitor kidney and heart function.

5 days

5 visits (in-person or at home)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of device-related side effects.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• AquaPass System

Trial Overview The REFORM-HF study tests the AquaPass System, a wearable suit designed to help remove excess body fluids through sweat in patients with heart failure. The goal is to see if it can eliminate an extra 500mL of fluid alongside usual medications either at home or outpatient settings.

How Is the Trial Designed?

Group I: AquaPass Experimental Treatment 1 Intervention

An AquaPass treatment session (up to 5-Hrs.) will be administered in the outpatient settings or at home and supervised by a certified study staff

Group II: Control Active Control 1 Intervention

An observation visit, during which data will be collected on fluid intake, fluid output, congestion score, body weight, and quality of life. These data will serve as a control for the efficacy primary endpoint comparison.

AquaPass System is already approved in United States for the following indications:

Approved in United States as AquaPass System for:

• Fluid overload in heart failure patients
• Chronic heart failure

Who Is Running the Clinical Trial?

AquaPass Medical Ltd.

Lead Sponsor

Trials

5

Recruited

120+

Published Research Related to This Trial

Loop diuretics are commonly used in congestive heart failure to relieve symptoms, but their long-term efficacy and safety remain uncertain, especially compared to venous ultrafiltration, which is currently being studied in acute decompensated heart failure patients.

There is a need for evidence-based treatment algorithms that incorporate clinical signs, kidney function, and biomarkers to optimize the use of loop diuretics and other medications in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loop diuretics and ultrafiltration in heart failure. Rossignol, P., Zannad, F.[2013]

In a study involving 11 advanced heart failure patients, the System 100 UF device was used for ultrafiltration, successfully removing significant amounts of fluid in 41% of treatments, with no major complications reported.

However, 45% of patients experienced worsening renal function during treatment, highlighting the need for controlled studies to better understand the safety and efficacy of ultrafiltration in high-risk heart failure populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a novel ultrafiltration device as a treatment strategy for diuretic resistant, refractory heart failure: initial clinical experience in a single center. Liang, KV., Hiniker, AR., Williams, AW., et al.[2013]

The Cardioband system effectively repairs severe functional mitral valve regurgitation in patients with advanced heart failure, showing significant elevation in cardiac troponin T (hsTnT) levels post-procedure, indicating myocardial stress but not damage.

Despite the increase in hsTnT, none of the five patients experienced clinical signs of myocardial infarction or deterioration in heart function, suggesting that the procedure is safe and does not lead to structural damage to the heart.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transient elevation of high-sensitive troponin T after Cardioband implantation. Kreusser, MM., Pleger, ST., Abu Sharar, H., et al.[2020]

Candesartan significantly reduces the risk of cardiovascular death and hospitalizations due to heart failure in patients with chronic heart failure and reduced left ventricular ejection fraction, showing a 18% lower risk of cardiovascular events compared to placebo over a median follow-up of 40 months.

The study also found that candesartan decreased all-cause mortality by 12% compared to placebo, although some patients experienced adverse effects like increased creatinine and hypotension, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality and morbidity reduction with Candesartan in patients with chronic heart failure and left ventricular systolic dysfunction: results of the CHARM low-left ventricular ejection fraction trials. Young, JB., Dunlap, ME., Pfeffer, MA., et al.[2021]

In a study of 149 heart failure patients, those treated with ultrafiltration experienced significantly greater weight loss and improvements in dyspnea scores and 6-minute walk distances compared to those receiving diuretics.

Both treatment groups showed similar safety profiles, with no significant differences in vital signs or kidney function markers, indicating that ultrafiltration is a safe and effective alternative to diuretics for managing heart failure in Chinese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Ultrafiltration in Patients with Heart Failure: A Single-Center Experience. Xiangli, S., Lan, L., Libiya, Z., et al.[2023]

Diuretic resistance in acute heart failure is a significant issue that can lead to worse health outcomes, highlighting the need for effective treatments.

The Doraya catheter is a new device aimed at improving diuretic response by regulating blood flow in the inferior vena cava, and it is currently being tested in a first-in-man clinical study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Diuretic Resistance with a Novel Percutaneous Blood Flow Regulator: Concept and Initial Experience. Dierckx, R., Vanderheyden, M., Heggermont, W., et al.[2020]

Heart failure is increasingly common, with many patients experiencing ongoing symptoms despite medication, highlighting the need for additional treatment options.

This review discusses various devices and interventions, such as left ventricular reconstruction and mechanical circulatory support, that can help improve heart function in patients with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Devices in heart failure--the new revolution. Gafoor, S., Franke, J., Lam, S., et al.[2015]

New device-based therapies for acute heart failure are being developed to improve symptoms and support heart and kidney function, classified under the DRI2P2S scheme based on their mechanisms of action.

These devices include various types such as dilators, removers, and inotropes, which aim to enhance treatment options for patients experiencing decompensated heart failure, as highlighted by recent preclinical and clinical trial results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device-based therapy for decompensated heart failure: An updated review of devices in development based on the DRI2P2S classification. de Oliveira Cardoso, C., Elgalad, A., Li, K., et al.[2022]

Patients with end-stage heart failure can benefit from novel cardiac support strategies like ventricular assist devices (VADs) and cardiac support devices (CSDs), which aim to improve heart function and structure.

While long-term VADs are effective, recovery after removal is rare; however, passive CSDs show promise for reversing heart damage and improving outcomes, particularly after severe heart attacks, though more research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and novel cardiac support therapies. Jugdutt, BI.[2021]

Current medications for heart failure (HF) have limited effectiveness in improving survival, particularly for acute heart failure (AHF) and heart failure with preserved ejection fraction (HFpEF).

Recent advancements in device therapies, such as left ventricular assist devices and other novel devices, show promise in treating or reversing HF by providing circulatory support and repairing heart abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in novel devices for the treatment of heart failure. Tang, R., Chang, Y., Song, J.[2023]

The Heartpod device developed by Savacor allows for real-time measurement of left atrial pressure in patients with congestive heart failure, enabling them to monitor their condition more effectively.

This innovative implantable device empowers patients to adjust their treatment based on precise intra-cardiac pressure data, potentially improving management of their heart failure symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Heartpod implantable heart failure therapy system. Walton, AS., Krum, H.[2022]

Ventricular assist devices, particularly left ventricular assist systems like the HeartMate, are effective in treating severe heart failure and can serve as both short- and long-term solutions for patients awaiting heart transplants.

These devices not only help patients survive until a transplant but also have the potential to improve heart function in some cases, suggesting they may become a more common alternative to transplantation in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development, evolution, and clinical utilization of artificial heart technology. Frazier, OH.[2004]

The Heartech left ventricular partitioning device (LVPD) was successfully implanted in 16 patients with chronic heart failure, showing a high success rate of 93.75% and no major adverse cardiovascular events reported in most patients during the 12-month follow-up.

Post-implantation, significant improvements were observed in heart function, including a reduction in left ventricular volumes and an increase in ejection fraction, as well as enhanced physical performance and quality of life, indicating the device's efficacy in managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Ventricular Restoration Prevents Left Ventricular Remodeling Post Myocardial Infarction: One-Year Evaluation of the Heartech First-in-man Study. Zhu, Z., Zhu, J., Yu, J., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05843201

AquaPass Device in Treatment of CHF Patients This study will examine safety, performance and usability of the AquaPass device in two phases: Phase 1: Hospitalization treatment. Phase 2: Home/outpatient ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36321445/

Enhancing Sweat Rate Using a Novel Device for the ... We aimed to study the feasibility and short-term performance of a novel approach to remove fluids and sodium directly from the interstitial compartment by ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/535989

Reducing Fluid Overload in Heart Failure Patients Using a ... The REFORM-HF study aims to test a new technology, AquaPass, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.

4. withpower.com withpower.com/trial/phase-chronic-heart-failure-chf-6-2024-3a5de

AquaPass System for Heart Failure (REFORM-HF Trial) These devices, including ventricular assist devices and cardiac support devices, have shown promise in improving heart function and quality of life for patients ...

5. ctv.veeva.com ctv.veeva.com/study/reducing-fluid-overload-in-heart-failure-patients-using-a-non-invasive-renal-independent-system

Reducing Fluid Overload in Heart Failure Patients Using a ... The REFORM-HF study aims to test a new technology, AquaPass, designed to assist patients experiencing symptoms of fluid overload due to ...