Lymph Drainage in Heart Failure

Heart Failure Clinical Trial

Official title:

Feasibility of Transcatheter Cannulation and Drainage of the Thoracic Duct in Patients With Congestive Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05240638
• Other study ID #: Pro00107814
• Status: Completed
• Phase: N/A
• Start date: October 24, 2022
• Est. completion date: July 7, 2023

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: July 7, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Marat Fudim	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success for access	Number of patients where TD was accessed successfully with an endovascular catheter under fluoroscopic or ultrasound guidance	At the time of the procedure
Primary	Safety defined as the absence of serious adverse events	Safety as measured by number of serious adverse events	Up to 24 hours post-procedure
Primary	Technical success for drainage	Number of patients where any amount of lymph was drained successfully from the TD with an endovascular catheter	At the time of the procedure
Secondary	Total fluid output (measured in mL) as measured by fluid collection	Total fluid output (measured in mL) as measured by fluid collection	Up to 24 hours post-procedure
Secondary	Change in body weight	Change in body weight	Pre-procedure, Post-procedure (up to 4 hours)
Secondary	Change in blood N-terminal Pro-BNP as measured by lab test	Change in blood N-terminal Pro-BNP as measured by lab test	Baseline, 12 hours, 24 hours post initiation of drainage
Secondary	Number of HF-related hospitalizations as measured by medical record review	Number of HF-related hospitalizations as measured by medical record review	30 days post-discharge