FLOWS-HF : Feasibility of Lymphatic Offloading with Stenting in Heart Failure

NCT06554912 | Withdrawn DMC

• 1 other identifier: 38RC24.0032
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Cardiovascular Diseases; Chronic Heart Failure

Keywords

Lymphatic Decompression; Chronic Heart Failure; Stenting; Lymphatic system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Evaluation of the lymphatic decompression's feasibility in heart failure

  Procedure day (D0-1)

• Evaluation of the lymphatic decompression's feasibility in heart failure

  Procedure day (D0-1)

• To evaluate the lymphatic decompression's efficacy in heart failure by change in heart failure symptoms. (urine output)

  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)

  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).

  During 180 days after the procedure +/- 4 days

Study Arms (1)

Lymphatic Decompression

EXPERIMENTAL

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

Interventions

Lymphatic Decompression PROCEDURE

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

Lymphatic Decompression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 under administrative or judicial supervision
• Subject unable to provide informed consent

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Selera Medical: collaborator

Related Publications (22)

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MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: August 15, 2024
• Study Start: December 20, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share