Back to resultsLymph Drainage in Heart Failure
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TD Drainage
Sponsored by
About this trial
This is an interventional device feasibility trial for Heart Failure focused on measuring heart catheterization, heart failure
Eligibility Criteria
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
Sites / Locations
- Marat FudimRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TD Drainage
Arm Description
Short term TD drainage
Outcomes
Primary Outcome Measures
Technical success for access
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
Safety as measured by number of serious adverse events
Technical success for drainage
Number of patients where any amount of lymph was drained successfully from the TD with an endovascular catheter
Secondary Outcome Measures
Total fluid output (measured in mL) as measured by fluid collection
Total fluid output (measured in mL) as measured by fluid collection
Change in body weight
Change in body weight
Change in blood N-terminal Pro-BNP as measured by lab test
Change in blood N-terminal Pro-BNP as measured by lab test
Number of HF-related hospitalizations as measured by medical record review
Number of HF-related hospitalizations as measured by medical record review
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05240638
Brief Title
Lymph Drainage in Heart Failure
Official Title
Feasibility of Transcatheter Cannulation and Drainage of the Thoracic Duct in Patients With Congestive Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
January 10, 2024 (Anticipated)
Study Completion Date
January 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart catheterization, heart failure
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TD Drainage
Arm Type
Experimental
Arm Description
Short term TD drainage
Intervention Type
Device
Intervention Name(s)
TD Drainage
Intervention Description
Image-guided percutaneous cannulation of the TD and drainage with an endovascular catheter (microcatheter)
Primary Outcome Measure Information:
Title
Technical success for access
Description
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
Title
Safety defined as the absence of serious adverse events
Description
Safety as measured by number of serious adverse events
Time Frame
Up to 24 hours post-procedure
Title
Technical success for drainage
Description
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 Outcome Measure Information:
Title
Total fluid output (measured in mL) as measured by fluid collection
Description
Total fluid output (measured in mL) as measured by fluid collection
Time Frame
Up to 24 hours post-procedure
Title
Change in body weight
Description
Change in body weight
Time Frame
Pre-procedure, Post-procedure (up to 4 hours)
Title
Change in blood N-terminal Pro-BNP as measured by lab test
Description
Change in blood N-terminal Pro-BNP as measured by lab test
Time Frame
Baseline, 12 hours, 24 hours post initiation of drainage
Title
Number of HF-related hospitalizations as measured by medical record review
Description
Number of HF-related hospitalizations as measured by medical record review
Time Frame
30 days post-discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marat Fudim
Phone
919-684-1284
Email
marat.fudim@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marat Fudim, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marat Fudim
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marat Fudim
Phone
917-544-4377
Email
marat.fudim@duke.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lymph Drainage in Heart Failure
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