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Lymph Drainage for Heart Failure

N/A
Waitlist Available
Led By Marat Fudim, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NYHA III- IV patients
Patients with heart failure volume overload
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 hours, 24 hours post initiation of drainage
Awards & highlights

Study Summary

This trial will test whether a drainage procedure can help improve symptoms for people with congestive heart failure.

Who is the study for?
This trial is for adults over 18 with heart failure who experience fluid overload and severe symptoms (NYHA III-IV). They must be scheduled for elective heart catheterization and able to give informed consent. It's not suitable for those with clotting disorders, iodine contrast allergies, high risk for catheterization as assessed by the investigator, active heart attacks, or ongoing infections.Check my eligibility
What is being tested?
The study is examining if draining lymph fluid can reduce congestion and ease breathing in patients with heart failure. Participants will undergo TD Drainage to see how it affects their condition.See study design
What are the potential side effects?
Potential side effects of TD Drainage may include discomfort at the drainage site, infection risk from the procedure, allergic reactions to materials used during treatment, and possible complications related to cardiac catheterization.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe heart condition symptoms.
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I have heart failure with fluid buildup.
Select...
I am scheduled for a procedure to check my heart's function.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of the procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of the procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety defined as the absence of serious adverse events
Technical success for access
Technical success for drainage
Secondary outcome measures
Change in blood N-terminal Pro-BNP as measured by lab test
Change in body weight
Number of HF-related hospitalizations as measured by medical record review
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TD DrainageExperimental Treatment1 Intervention
Short term TD drainage
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TD Drainage
2022
N/A
~10

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,359 Previous Clinical Trials
3,420,221 Total Patients Enrolled
63 Trials studying Heart Failure
46,516 Patients Enrolled for Heart Failure
Marat Fudim, MDPrincipal InvestigatorDuke University

Media Library

TD Drainage (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05240638 — N/A
Heart Failure Research Study Groups: TD Drainage
Heart Failure Clinical Trial 2023: TD Drainage Highlights & Side Effects. Trial Name: NCT05240638 — N/A
TD Drainage (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05240638 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there currently a call for volunteers to join this clinical research?

"According to clinicaltrials.gov, this experiment is now recruiting patients from the time of its inaugural posting on October 1st 2022 until it was most recently updated ten days later."

Answered by AI

What are the intended outcomes of this experiment?

"This study is designed to measure the technical success of drainage over a 24 hour duration, as well as count HF-related hospitalizations via medical record review. Additionally, blood N-terminal Pro BNP levels and total fluid output will be monitored through lab tests and collection respectively."

Answered by AI

What is the total number of participants in this medical experiment?

"Affirmative. The clinical trial's page on the website clinicaltrials.gov states that it is currently in search of participants, having been posted initially on October 1st 2022 and last updated 10 days later on the tenth day of October 2022. It requires a total of 10 people to be recruited from one location."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
Marat Fudim
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Lymph Drainage in Heart Failure
2022. "Lymph Drainage in Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05240638.
~0 spots leftby Apr 2025
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