Heart FailureNCT05240638
Lymph Drainage in Heart Failure
A study testing TD Drainage in people with Heart Failure, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- TD Drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2022to 7 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- TD Drainage
- Keywords
- heart catheterization, heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD DrainageDevice
Image-guided percutaneous cannulation of the TD and drainage with an endovascular catheter (microcatheter)
| Study group | Role | What they receive |
|---|---|---|
| TD Drainage | Experimental | Short term TD drainage Receives: Device: TD Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success for access
Number of patients where TD was accessed successfully with an endovascular catheter under fluoroscopic or ultrasound guidance
Measured: At the time of the procedure
Safety defined as the absence of serious adverse events
Safety as measured by number of serious adverse events
Measured: Up to 24 hours post-procedure
Technical success for drainage
Number of patients where any amount of lymph was drained successfully from the TD with an endovascular catheter
Measured: At the time of the procedure
Secondary outcomes (4)
Total fluid output (measured in mL) as measured by fluid collection
Total fluid output (measured in mL) as measured by fluid collection
Measured: Up to 24 hours post-procedure
Change in body weight
Change in body weight
Measured: Pre-procedure, Post-procedure (up to 4 hours)
Change in blood N-terminal Pro-BNP as measured by lab test
Change in blood N-terminal Pro-BNP as measured by lab test
Measured: Baseline, 12 hours, 24 hours post initiation of drainage
Number of HF-related hospitalizations as measured by medical record review
Number of HF-related hospitalizations as measured by medical record review
Measured: 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start24 Oct 2022
- Primary completion5 May 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marat Fudim, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240638
- Sponsor's protocol ID
- Pro00107814
- Status last verified
- Feb 2024
- First submitted
- 10 Jan 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Transcatheter Cannulation and Drainage of the Thoracic Duct in Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT05240638
- Acronym / sponsor ID
- Pro00107814
- Conditions
- Heart Failure
- Keywords
- heart catheterization, heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TD Drainage | Experimental | Device: TD DrainageShort term TD drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TD DrainageImage-guided percutaneous cannulation of the TD and drainage with an endovascular catheter (microcatheter) | Device | TD Drainage |
Primary outcome
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
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
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
4 secondary outcomes
Total fluid output (measured in mL) as measured by fluid collection
Time frame: Up to 24 hours post-procedure
Change in body weight
Time frame: 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
Number of HF-related hospitalizations as measured by medical record review
Time frame: 30 days post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marat Fudim, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TD Drainage in people with Heart Failure, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success for access (time frame: At the time of the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024; AzTrials last refreshed its copy on 5 Nov 2026.