Lymph Drainage in Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: TD Drainage

• Registration Number: NCT05240638
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-15
• Study Start: 2022-10-24
• Primary Completion: 2023-05-05
• Study Completion: 2023-07-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TD Drainage	TD Drainage	Short term TD drainage

Primary Outcome Measures

Name	Time	Method
Technical success for access	At the time of the procedure	Number of patients where TD was accessed successfully with an endovascular catheter under fluoroscopic or ultrasound guidance
Safety defined as the absence of serious adverse events	Up to 24 hours post-procedure	Safety as measured by number of serious adverse events
Technical success for drainage	At the time of the procedure	Number of patients where any amount of lymph was drained successfully from the TD with an endovascular catheter

Secondary Outcome Measures

Name	Time	Method
Number of HF-related hospitalizations as measured by medical record review	30 days post-discharge	Number of HF-related hospitalizations as measured by medical record review
Total fluid output (measured in mL) as measured by fluid collection	Up to 24 hours post-procedure	Total fluid output (measured in mL) as measured by fluid collection
Change in body weight	Pre-procedure, Post-procedure (up to 4 hours)	Change in body weight
Change in blood N-terminal Pro-BNP as measured by lab test	Baseline, 12 hours, 24 hours post initiation of drainage	Change in blood N-terminal Pro-BNP as measured by lab test

Trial Locations

Locations (1)

Marat Fudim; 🇺🇸 Durham, North Carolina, United States