Lymph Drainage in Heart Failure

Duke University1 enrolled

Overview

This study aims to test the safety and efficacy of lymph fluid drainage on heart congestion and shortness of breath symptoms among patients participants with heart failure.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

TD DrainageDEVICE

Image-guided percutaneous cannulation of the TD and drainage with an endovascular catheter (microcatheter)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years or older * Subjects with informed consent to participate * NYHA III- IV patients * Patients with heart failure volume overload * Planned for elective right heart catheterization Exclusion Criteria: * Active coronary syndrome (type I myocardial infarction) * Local infection or ongoing systemic infection(s) * Thrombotic coagulation disorder * On continuous blood thinners that cannot be discontinued or held * Allergy or contraindications to the use of iodine-based contrast agents * Subjects deemed to be high risk for performing a cardiac catheterization by study investigator

Locations (1)

Marat Fudim

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Technical success for access

Number of patients where TD was accessed successfully with an endovascular catheter under fluoroscopic or ultrasound guidance

Time frame: At the time of the procedure

Safety defined as the absence of serious adverse events

Safety as measured by number of serious adverse events

Time frame: Up to 24 hours post-procedure

Technical success for drainage

Number of patients where any amount of lymph was drained successfully from the TD with an endovascular catheter

Time frame: At the time of the procedure

Secondary Outcomes

Total fluid output (measured in mL) as measured by fluid collection

Time frame: Up to 24 hours post-procedure

Change in body weight

Time frame: Pre-procedure, Post-procedure (up to 4 hours)

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

Time frame: Baseline, 12 hours, 24 hours post initiation of drainage

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

Time frame: 30 days post-discharge

Data from ClinicalTrials.gov

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