Status:
WITHDRAWN
FLOWS-HF : Feasibility of Lymphatic Offloading with Stenting in Heart Failure
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Selera Medical
Conditions:
Cardiovascular Diseases
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 r...
Detailed Description
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 precl...
Eligibility Criteria
Inclusion
- Subjects ≥18 years of age
- Diagnosis of chronic heart failure (reduced or preserved EF) with evidence of diastolic dysfunction on echocardiogram
- Chronic NYHA class II or greater
- Prone to cardiorenal syndrome or refractory to diuretics (e.g. on lasix 125 mg PO total daily dose or equivalent diuretic dosing for 1 or more months prior to enrollment)
- History of symptoms of congestion (e.g. dyspnea, peripheral edema, pleural effusion, and/or ascites) in preceding 12 months requiring HF hospitalization with IV diuresis
- NT-proBNP \>1000 pg/ml
- eGFR \> 20 ml/min/1.73m2
- Life expectancy \> 6 months
- Membership of the social security system or benefiting from such a system
- Able and willing to sign informed consent
Exclusion
- Anatomy not considered suitable based on CT with contrast (e.g., not visible, multiple terminal ducts or plexiform termination)
- Other cause of thoracic duct congestion based on CT with contrast (superior cava vein/left brachiocephalic vein/ jugular or subclavian vein thrombosis)
- Acute coronary syndrome, stroke, pulmonary embolism in previous 6 months
- Stage IV or stage V chronic kidney disease, or end-stage renal disease (ESRD) requiring dialysis, or severe renal failure (\<30ml/min)
- Cardiac surgery within past 6 months (coronary artery bypass grafting, valvular, or pericardial surgery)
- Transcatheter structural heart intervention within past 6 months
- Active pregnancy, breastfeeding, or anticipated pregnancy within 1 year
- Known coagulation disorders or inability to take blood thinning medications (anticoagulation or antiplatelet therapy) for at least one month after procedure
- Severe pulmonary hypertension (RVSP \>60mmHg as assessed by echocardiogram)
- Severe RV dysfunction (TAPSE \<17mm, RFAC \<35%)
- Known allergies or sensitivities to materials utilized in procedure, including contrast agents
- Candidate deemed unsuitable based on investigator opinion
- Subject in exclusion period of another study
- Subject under administrative or judicial supervision
- Subject unable to provide informed consent
Key Trial Info
Start Date :
December 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06554912
Start Date
December 20 2024
End Date
December 20 2024
Last Update
December 27 2024
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