An interventional study of Lymphatic Decompression in Cardiovascular Diseases and Chronic Heart Failure, sponsored by University Hospital, Grenoble. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Supportive care
The main objective is to evaluate the safety of lymphatic decompression in heart failure.
The research hypothesis is that lymphatic decompression is safe and feasible in heart failure patients with recurrent congestion despite on maximum tolerated diuretic dosage. Safety will be evaluated by the rate and severity of adverse events. Feasibility will be assess based on procedural success and time.
In demonstrating that this approach is both safe and feasible, the expected benefits of the research include symptom relief for patients as well as data generation and considerations for a novel treatment for chronic heart failure patients. Ultimately, this research will contribute to the development of an additional treatment option for patients that remain congested while on standard-of-care therapies.
Better understanding of the lymphatic system's role in managing volume status and how this system is overwhelmed in HF has made it a compelling target for intervention. Historic and contemporary preclinical and clinical evidence demonstrate that surgically relieving or bypassing the resistance at the LVJ when the lymphatic system is overwhelmed significantly improves volume status in heart failure. Although it demonstrates clinical benefit in a majority of patients, the surgical approach has greater risks and is not scalable due to technical difficulties. More recently, improved clinical outcomes and feasibility of minimally invasive lymphatic decompression via transcatheter thoracic duct stenting was demonstrated in cirrhosis, another volume-overload related condition. With supportive preclinical and clinical data, this study aims to evaluate lymphatic decompression in heart failure.
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Exclusion Criteria:
Pre-procedural evaluation : CT with contrast injected in the right arm, baseline heart failure questionaries and assessments Study intervention : Transvenous retrograde access of the thoracic duct, hemodynamic measures, measurement of central venous and thoracic duct pressures, lymphovenous junction stenting, fluid sampling Follow-up evaluation : phone calls on days 2 and 7 to assess adverse events and in-person consultations including adverse events, heart failure questionaries and assessments at 1, 3, and 6 months
Procedure: Lymphatic Decompression
Patients will be prepared according to standard procedures Clinical examinations, para-clinical assessment and biological tests Patient will be set in angiography room and local anesthesia at the puncture area (femoral vein or brachial vein). Obtain access to the femoral vein per standard procedures (option for brachial access depending on anatomy based on pre-operative CT, per physician discretion) After setting introducer sheath, catheterism of cardiac cavity will be performed for assess the following standard hemodynamic measures Catheterism of thoracic duct through the subclavian vein will be performed under fluoro guidance and phlebography using contrast Measure TD and central venous pressures Deploy stent under fluoro guidance Standard vascular stent deployed in subclavian vein and into lymphovenous junction Evaluate the procedure with standard phlebography and hemodynamic measures Remove catheters, and temporary compression as standard venous procedures
Evaluation of the lymphatic decompression's safety in heart failure by the assessment of the rate and severity of adverse events after the procedure of thoracic duct decompression.
Assessment of the rate and severity of adverse events after the procedure of thoracic duct decompression.
Time frame: During 180 days after the procedure +/- 4 days
Evaluation of the lymphatic decompression's feasibility in heart failure
Lymphatic decompression's success (Y/N)
Time frame: Procedure day (D0-1)
Evaluation of the lymphatic decompression's feasibility in heart failure
Procedure time (intervention time in minutes)
Time frame: Procedure day (D0-1)
To evaluate the lymphatic decompression's efficacy in heart failure by change in heart failure symptoms. (urine output)
Change in HF symptoms, including urine output (mL)
Time frame: During 180 days after the procedure +/- 4 days
To evaluate the lymphatic decompression's efficacy in heart failure by change in heart failure symptoms. (sodium output)
Change in HF symptoms, including sodium output (mmol/L/24h)
Time frame: During 180 days after the procedure +/- 4 days
To evaluate the lymphatic decompression's efficacy in heart failure by change in heart failure symptoms. (medication dosing requirements).
Change in HF symptoms, including medication dosing requirements
Time frame: During 180 days after the procedure +/- 4 days
To evaluate the lymphatic decompression's efficacy in heart failure by change in heart failure symptoms. (KCCQ quality of life score)
Change in HF symptoms, including KCCQ quality of life score (scaled from 0 to 100 and represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent).
Time frame: During 180 days after the procedure +/- 4 days
To evaluate the lymphatic decompression's efficacy in heart failure by change in heart failure symptoms. (EVEREST congestion score)
Change in HF symptoms, including EVEREST congestion score (based on specific symptoms and signs ranges from 0 to 3 for each symptom or sign)
Time frame: During 180 days after the procedure +/- 4 days
To evaluate the lymphatic decompression's efficacy in heart failure by change in heart failure symptoms. (6-min walk test)
Change in HF symptoms, including 6-min walk test (The distance in metres walked reflects the patient's functional capacity)
Time frame: During 180 days after the procedure +/- 4 days
To evaluate the lymphatic decompression's efficacy in heart failure by change in heart failure symptoms. (number of heart failure hospitalization)
Change in HF symptoms, including number of HF hospitalization
Time frame: During 180 days after the procedure +/- 4 days
To evaluate the lymphatic decompression's efficacy in heart failure by change in heart failure symptoms. (IV diuresis rates)
Change in HF symptoms, including IV diuresis rates (mg/day)
Time frame: During 180 days after the procedure +/- 4 days
To evaluate the lymphatic decompression's efficacy in heart failure by change in heart failure symptoms. (frequency of paracentesis)
Change in HF symptoms, including frequency of paracentesis (mg/L)
Time frame: During 180 days after the procedure +/- 4 days
To evaluate the lymphatic decompression's efficacy in heart failure by change in heart failure symptoms. (frequency of thoracentesis)
Change in HF symptoms, including frequency of thoracentesis (mg/L)
Time frame: During 180 days after the procedure +/- 4 days
Evaluation of the lymphatic decompression's impact on thoracic duct pressure
Change in pressure gradient across lymphovenous junction before and after stenting
Time frame: Before the procedure and days 90 +/- 4 days after the procedure
Evaluation of the lymphatic decompression's impact on central hemodynamic functions. (Blood flow dynamics in mmHg).
Changes in hemodynamic measures during intervention evaluated by catheter in right cavities before decompression, 30 minutes after decompression and 3 months after the procedure.
Time frame: Days 30, Days 90 and days 180 after the procedure
Evaluation of the lymphatic decompression's impact on renal function
Changes in creatinine / eGFR before and after the procedure (M1, M3, M6).
Time frame: Days 30, Days 90 and days 180 after the procedure
No study locations are listed for this record.
Plan to share: No
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University Hospital, Grenoble