FLOWS-HF : Feasibility of Lymphatic Offloading with Stenting in Heart Failure
NCT ID: NCT06554912
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2024-12-20
2024-12-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lymphatic Decompression
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Selera Medical
UNKNOWN
University Hospital, Grenoble
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
References
Explore related publications, articles, or registry entries linked to this study.
Osenenko KM, Kuti E, Deighton AM, Pimple P, Szabo SM. Burden of hospitalization for heart failure in the United States: a systematic literature review. J Manag Care Spec Pharm. 2022 Feb;28(2):157-167. doi: 10.18553/jmcp.2022.28.2.157.
Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.
Cotter G, Metra M, Milo-Cotter O, Dittrich HC, Gheorghiade M. Fluid overload in acute heart failure--re-distribution and other mechanisms beyond fluid accumulation. Eur J Heart Fail. 2008 Feb;10(2):165-9. doi: 10.1016/j.ejheart.2008.01.007.
Miller WL. Fluid Volume Overload and Congestion in Heart Failure: Time to Reconsider Pathophysiology and How Volume Is Assessed. Circ Heart Fail. 2016 Aug;9(8):e002922. doi: 10.1161/CIRCHEARTFAILURE.115.002922.
Uduman J. Epidemiology of Cardiorenal Syndrome. Adv Chronic Kidney Dis. 2018 Sep;25(5):391-399. doi: 10.1053/j.ackd.2018.08.009.
Miller WL. Fluid Volume Homeostasis in Heart Failure: A Tale of 2 Circulations. J Am Heart Assoc. 2022 Sep 20;11(18):e026668. doi: 10.1161/JAHA.122.026668. Epub 2022 Sep 8.
Rengstorff RH. Astigmatism after contact lens wear. Am J Optom Physiol Opt. 1977 Nov;54(11):787-91. doi: 10.1097/00006324-197711000-00008.
Neuberg GW, Miller AB, O'Connor CM, Belkin RN, Carson PE, Cropp AB, Frid DJ, Nye RG, Pressler ML, Wertheimer JH, Packer M; PRAISE Investigators. Prospective Randomized Amlodipine Survival Evaluation. Diuretic resistance predicts mortality in patients with advanced heart failure. Am Heart J. 2002 Jul;144(1):31-8. doi: 10.1067/mhj.2002.123144.
Shams E, Bonnice S, Mayrovitz HN. Diuretic Resistance Associated With Heart Failure. Cureus. 2022 Jan 18;14(1):e21369. doi: 10.7759/cureus.21369. eCollection 2022 Jan.
Itkin M, Rockson SG, Burkhoff D. Pathophysiology of the Lymphatic System in Patients With Heart Failure: JACC State-of-the-Art Review. J Am Coll Cardiol. 2021 Jul 20;78(3):278-290. doi: 10.1016/j.jacc.2021.05.021.
Fudim M, Salah HM, Sathananthan J, Bernier M, Pabon-Ramos W, Schwartz RS, Rodes-Cabau J, Cote F, Khalifa A, Virani SA, Patel MR. Lymphatic Dysregulation in Patients With Heart Failure: JACC Review Topic of the Week. J Am Coll Cardiol. 2021 Jul 6;78(1):66-76. doi: 10.1016/j.jacc.2021.04.090.
Martens P, Tang WHW. Targeting the Lymphatic System for Interstitial Decongestion. JACC Basic Transl Sci. 2021 Nov 22;6(11):882-884. doi: 10.1016/j.jacbts.2021.10.003. eCollection 2021 Nov.
Aronson D. The interstitial compartment as a therapeutic target in heart failure. Front Cardiovasc Med. 2022 Aug 17;9:933384. doi: 10.3389/fcvm.2022.933384. eCollection 2022.
Mortimer PS, Rockson SG. New developments in clinical aspects of lymphatic disease. J Clin Invest. 2014 Mar;124(3):915-21. doi: 10.1172/JCI71608. Epub 2014 Mar 3.
Ratnayake CBB, Escott ABJ, Phillips ARJ, Windsor JA. The anatomy and physiology of the terminal thoracic duct and ostial valve in health and disease: potential implications for intervention. J Anat. 2018 Jul;233(1):1-14. doi: 10.1111/joa.12811. Epub 2018 Apr 10.
Witte MH, Dumont AE, Clauss RH, Rader B, Levine N, Breed ES. Lymph circulation in congestive heart failure: effect of external thoracic duct drainage. Circulation. 1969 Jun;39(6):723-33. doi: 10.1161/01.cir.39.6.723. No abstract available.
Cole WR, Witte MH, Kash SL, Rodger M, Bleisch WR, Muelheims GH. Thoracic duct-to-pulmonary vein shunt in the treatment of experimental right heart failure. Circulation. 1967 Oct;36(4):539-43. doi: 10.1161/01.cir.36.4.539. No abstract available.
Dumont AE. The flow capacity of the thoracic duct-venous junction. Am J Med Sci. 1975 May-Jun;269(3):292-301. doi: 10.1097/00000441-197505000-00001. No abstract available.
Ghelfi J, Brusset B, Teyssier Y, Sengel C, Gerster T, Girard E, Roth G, Bellier A, Bricault I, Decaens T. Endovascular Lymphatic Decompression via Thoracic Duct Stent Placement for Refractory Ascites in Patients with Cirrhosis: A Pilot Study. J Vasc Interv Radiol. 2023 Feb;34(2):212-217. doi: 10.1016/j.jvir.2022.10.030. Epub 2022 Oct 25.
Abraham WT, Jonas M, Dongaonkar RM, Geist B, Ueyama Y, Render K, Youngblood B, Muir W, Hamlin R, Del Rio CL. Direct Interstitial Decongestion in an Animal Model of Acute-on-Chronic Ischemic Heart Failure. JACC Basic Transl Sci. 2021 Nov 22;6(11):872-881. doi: 10.1016/j.jacbts.2021.09.008. eCollection 2021 Nov.
Serenyi P, Magyar Z, Szabo G. Cervical lymphato-venous shunt in treatment of ascites in caval-constricted dogs and in patients with hepatic cirrhosis. Experimental observations and 7 years clinical experience. Lymphology. 1976 Jun;9(2):53-61.
Khalilzadeh O, Baerlocher MO, Shyn PB, Connolly BL, Devane AM, Morris CS, Cohen AM, Midia M, Thornton RH, Gross K, Caplin DM, Aeron G, Misra S, Patel NH, Walker TG, Martinez-Salazar G, Silberzweig JE, Nikolic B. Proposal of a New Adverse Event Classification by the Society of Interventional Radiology Standards of Practice Committee. J Vasc Interv Radiol. 2017 Oct;28(10):1432-1437.e3. doi: 10.1016/j.jvir.2017.06.019. Epub 2017 Jul 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
38RC24.0032
Identifier Type: -
Identifier Source: org_study_id