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OpenTrials
Completed

NCT Number: NCT05240638

Lymph Drainage in 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marat Fudim

Durham, North Carolina, 27710-0001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TD Drainage

Device

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. Change in body weight

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

    Change in body weight

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2022
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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