What side effects are associated with this type of intervention?

Common treatments for heart failure that modulate renal perfusion or venous return, such as diuretics, ACE inhibitors, ARBs, and beta-blockers, have several known side effects. Diuretics can cause electrolyte imbalances, dehydration, and kidney dysfunction. ACE inhibitors and ARBs may lead to hyperkalemia, hypotension, and renal impairment. Beta-blockers can cause bradycardia, hypotension, and fatigue. These side effects necessitate careful monitoring and dose adjustments to ensure patient safety.

What prior FDA approvals exist?

FDA-approved treatments for heart failure that manage fluid overload and renal perfusion include diuretics like furosemide, which help reduce fluid retention by increasing urine output. Additionally, vasodilators such as ACE inhibitors (e.g., enalapril) and ARBs (e.g., losartan) improve renal perfusion and reduce the workload on the heart. These treatments aim to alleviate symptoms and improve quality of life in heart failure patients by managing fluid balance and enhancing kidney function.

What other types of research exist?

Promising alternatives to the Doraya Catheter for heart failure patients include: 1) SGLT2 inhibitors (e.g., empagliflozin) which have shown benefits in reducing heart failure hospitalizations and improving renal outcomes. 2) Novel diuretics like tolvaptan, which can manage fluid overload by promoting aquaresis without significant electrolyte imbalance. 3) The BAROSTIM NEO System, a neuromodulation device that improves heart function and fluid management by stimulating the baroreceptors. 4) The CardioMEMS HF System, an implantable pulmonary artery pressure monitoring device that allows for proactive management of fluid status in heart failure patients.

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Device

Doraya Catheter for Heart Failure

N/A

Recruiting

Research Sponsored by Revamp Medical Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is hospitalized with primary diagnosis of ADHF

Subject insufficiently responds to IV diuretic therapy

Must not have

Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \severe regurgitation) or Severe mitral disease with planned intervention

Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline [pre intervention] and accumulated through 24 hours [t=0-24 hours]

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the Doraya Catheter, a device that helps manage fluid levels, in heart failure patients who do not respond well to typical treatments. The catheter works by controlling and managing excess fluid in the body.

Who is the study for?

This trial is for hospitalized patients with acute decompensated heart failure (ADHF) who aren't responding well to IV diuretics. They must have fluid overload and high levels of certain heart-related biomarkers. It's not for those with very low blood pressure, recent heart attacks or interventions, complex congenital heart disease, severe valve disorders, active infections, or critical damage in multiple body systems.

What is being tested?

The DORAYA-HF study is testing the Doraya Catheter's ability to manage fluid overload in ADHF patients who don't respond adequately to standard diuretic therapy. The goal is to assess how feasible and safe this catheter is when used in a real-world clinical setting.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include complications related to catheter insertion such as bleeding or infection at the site of entry, discomfort during the procedure, and any unforeseen reactions related to the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in the hospital because of acute heart failure.

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IV diuretics do not work well for me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe heart valve problem or need surgery for it.

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I have a serious heart condition like myocarditis or cardiomyopathy.

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I have a complex heart condition from birth.

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I have an ongoing infection with a fever over 100°F or it's not improving with antibiotics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline [pre intervention] and accumulated through 24 hours [t=0-24 hours]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline [pre intervention] and accumulated through 24 hours [t=0-24 hours]

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline [pre intervention] and accumulated through 24 hours [t=0-24 hours] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Serious Adverse Events

Urine Output

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ADHF patientsExperimental Treatment1 Intervention

ADHF patients with insufficient response to diuretics treated with the Doraya catheter

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doraya catheter

2018

N/A

~10

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure include diuretics, which reduce fluid overload by promoting urine production; ACE inhibitors and ARBs, which lower blood pressure and reduce strain on the heart by inhibiting the renin-angiotensin system; and beta-blockers, which decrease heart rate and improve heart function. Devices like the Doraya Catheter modulate renal perfusion or venous return to manage fluid overload, directly addressing one of the primary symptoms of heart failure. These treatments are essential as they help alleviate symptoms, prevent hospitalizations, and improve survival rates in heart failure patients.