Lymph Drainage in Heart Failure

February 22, 2024 updated by: Duke University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710-0001
        • Marat Fudim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TD Drainage
Short term TD drainage
Device: TD Drainage
Image-guided percutaneous cannulation of the TD and drainage with an endovascular catheter (microcatheter)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success for access
Time Frame: At the time of the procedure
Number of patients where TD was accessed successfully with an endovascular catheter under fluoroscopic or ultrasound guidance
At the time of the procedure
Safety defined as the absence of serious adverse events
Time Frame: Up to 24 hours post-procedure
Safety as measured by number of serious adverse events
Up to 24 hours post-procedure
Technical success for drainage
Time Frame: At the time of the procedure
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Marat Fudim, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2022

Primary Completion (Actual)

May 5, 2023

Study Completion (Actual)

July 7, 2023

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00107814

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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