What side effects are associated with this type of intervention?

Common treatments for heart failure that focus on fluid management and symptom relief, such as diuretics, ACE inhibitors, beta-blockers, and fluid drainage techniques, have various side effects. Diuretics can cause electrolyte imbalances, dehydration, and kidney dysfunction. ACE inhibitors may lead to cough, elevated blood potassium levels, and kidney impairment. Beta-blockers can cause fatigue, bradycardia, and hypotension. Fluid drainage techniques, like lymph fluid drainage, may result in localized discomfort, infection risk, and potential damage to surrounding tissues. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

FDA-approved treatments for heart failure that focus on reducing fluid buildup and alleviating heart congestion include diuretics such as furosemide, which help remove excess fluid from the body. Other medications include ACE inhibitors (e.g., enalapril), beta-blockers (e.g., metoprolol), and aldosterone antagonists (e.g., spironolactone), which improve heart function and reduce symptoms. These treatments aim to manage fluid retention, improve cardiac output, and enhance overall quality of life for heart failure patients.

What other types of research exist?

Promising novel alternatives to lymph fluid drainage for heart failure patients include: 1) SGLT2 inhibitors (e.g., empagliflozin, dapagliflozin) which have shown benefits in reducing hospitalization and improving cardiovascular outcomes; 2) ARNI (angiotensin receptor-neprilysin inhibitors, e.g., sacubitril/valsartan) which improve heart function and reduce fluid buildup; 3) Cardiac contractility modulation (CCM) devices that enhance heart muscle contractions; and 4) Novel diuretics like tolvaptan that specifically target fluid overload without significant electrolyte imbalance.

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Lymph Drainage for Heart Failure

N/A

Waitlist Available

Led By Marat Fudim, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

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

Must have

NYHA III- IV patients

Patients with heart failure volume overload

Must not have

Thrombotic coagulation disorder

Allergy or contraindications to the use of iodine-based contrast agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 hours, 24 hours post initiation of drainage

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if removing extra fluid from the body can help people with heart failure breathe easier and reduce heart congestion. A method to remove excess fluid in heart failure patients has shown potential benefits in reducing the need for hospital visits and improving symptoms.

Who is the study for?

This trial is for adults over 18 with heart failure who experience fluid overload and severe symptoms (NYHA III-IV). They must be scheduled for elective heart catheterization and able to give informed consent. It's not suitable for those with clotting disorders, iodine contrast allergies, high risk for catheterization as assessed by the investigator, active heart attacks, or ongoing infections.

What is being tested?

The study is examining if draining lymph fluid can reduce congestion and ease breathing in patients with heart failure. Participants will undergo TD Drainage to see how it affects their condition.

What are the potential side effects?

Potential side effects of TD Drainage may include discomfort at the drainage site, infection risk from the procedure, allergic reactions to materials used during treatment, and possible complications related to cardiac catheterization.

Eligibility Criteria

Inclusion Criteria

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

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I have severe heart condition symptoms.

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I have heart failure with fluid buildup.

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I am scheduled for a procedure to check my heart's function.

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I am 18 years old or older.

Exclusion Criteria

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

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I have a blood clotting disorder.

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I am allergic to iodine-based contrast agents.

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I am on permanent blood thinners that cannot be stopped.

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I have had a recent heart attack.

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I do not have any current infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the time of the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the time of the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of the procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety defined as the absence of serious adverse events

Technical success for access

Technical success for drainage

Secondary study objectives

Change in blood N-terminal Pro-BNP as measured by lab test

Change in body weight

Number of HF-related hospitalizations as measured by medical record review

+1 more

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: TD DrainageExperimental Treatment1 Intervention

Short term TD drainage

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TD Drainage

2022

N/A

~10

0 / 9Eligibility 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 focus on reducing fluid buildup and improving heart function. Diuretics help remove excess fluid from the body, reducing swelling and easing breathing difficulties. ACE inhibitors and ARBs relax blood vessels, lowering blood pressure and decreasing the heart's workload. Beta-blockers slow the heart rate and reduce blood pressure, enhancing heart efficiency. These treatments are essential for heart failure patients as they alleviate symptoms, improve quality of life, and decrease the risk of hospitalizations.