FLOWS-HF : Feasibility of Lymphatic Offloading With Stenting in Heart Failure
NCT Number: NCT06554912
Acronym: FLOW-HF
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Diseases|Chronic Heart Failure
Interventions: PROCEDURE: Lymphatic Decompression
Sponsor: University Hospital, Grenoble
Collaborators: Selera Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2026-10

Summary:
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.

Primary Outcome Measures: 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., During 180 days after the procedure +/- 4 days
Secondary Outcome Measures: Evaluation of the lymphatic decompression's feasibility in heart failure, Lymphatic decompression's success (Y/N), Procedure day (D0-1)|Evaluation of the lymphatic decompression's feasibility in heart failure, Procedure time (intervention time in minutes), 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), 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), 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, 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)., 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), 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), 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, 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), 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), 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), 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, 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., 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)., Days 30, Days 90 and days 180 after the procedure