Cardiovascular DiseasesFLOW-HFNCT06554912
FLOWS-HF : Feasibility of Lymphatic Offloading With Stenting in Heart Failure
A study testing Lymphatic Decompression in people with Cardiovascular Diseases and Chronic Heart Failure, run by University Hospital, Grenoble.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Chronic Heart Failure
- What is being tested?
- Lymphatic Decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
Official title: Evaluation of Safety and Feasibility of Lymphatic Decompression in Chronic Heart Failure
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.
Read the 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 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.
- Conditions
- Cardiovascular Diseases, Chronic Heart Failure
- Being tested
- Lymphatic Decompression
- Keywords
- Lymphatic Decompression, Chronic Heart Failure, Stenting, Lymphatic system
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphatic DecompressionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Lymphatic Decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 180 days after the procedure +/- 4 days
Secondary outcomes (15)
Evaluation of the lymphatic decompression's feasibility in heart failure
Lymphatic decompression's success (Y/N)
Measured: Procedure day (D0-1)
Evaluation of the lymphatic decompression's feasibility in heart failure
Procedure time (intervention time in minutes)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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).
Measured: Days 30, Days 90 and days 180 after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start20 Dec 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Why it stopped: stop financial collaboration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Selera Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554912
- Sponsor's protocol ID
- 38RC24.0032
- Acronym
- FLOW-HF
- Status last verified
- Dec 2024
- First submitted
- 25 Apr 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35098748Ambrosy 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.
PubMed 24491689Cotter 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.
PubMed 18279771Miller 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.
PubMed 27436837Uduman J. Epidemiology of Cardiorenal Syndrome. Adv Chronic Kidney Dis. 2018 Sep;25(5):391-399. doi: 10.1053/j.ackd.2018.08.009.
PubMed 30309456Miller 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.
PubMed 36073644Rengstorff RH. Astigmatism after contact lens wear. Am J Optom Physiol Opt. 1977 Nov;54(11):787-91. doi: 10.1097/00006324-197711000-00008.
PubMed 610440Neuberg 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.
PubMed 12094185Shams 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.
PubMed 35198282Itkin 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.
PubMed 34266581Fudim 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.
PubMed 34210416Martens 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.
PubMed 34869952Aronson 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.
PubMed 36061549Mortimer 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.
PubMed 24590276Ratnayake 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.
PubMed 29635686
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Feasibility of Lymphatic Decompression in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT06554912
- Acronym / sponsor ID
- FLOW-HF / 38RC24.0032
- Conditions
- Cardiovascular Diseases, Chronic Heart Failure
- Keywords
- Lymphatic Decompression, Chronic Heart Failure, Stenting, Lymphatic system
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: stop financial collaboration
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Selera Medical
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphatic Decompression | Experimental | Procedure: Lymphatic DecompressionPre-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymphatic DecompressionPatients 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 | Procedure or surgery | Lymphatic Decompression |
Primary outcome
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.
Time frame: During 180 days after the procedure +/- 4 days
Assessment of the rate and severity of adverse events after the procedure of thoracic duct decompression.
15 secondary outcomes
Evaluation of the lymphatic decompression's feasibility in heart failure
Time frame: Procedure day (D0-1)
Evaluation of the lymphatic decompression's feasibility in heart failure
Time frame: Procedure day (D0-1)
To evaluate the lymphatic decompression's efficacy in heart failure by change in heart failure symptoms. (urine output)
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)
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).
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)
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)
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)
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)
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)
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)
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)
Time frame: During 180 days after the procedure +/- 4 days
Evaluation of the lymphatic decompression's impact on thoracic duct pressure
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).
Time frame: Days 30, Days 90 and days 180 after the procedure
Evaluation of the lymphatic decompression's impact on renal function
Time frame: Days 30, Days 90 and days 180 after the procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Results publication: PubMed 35098748Osenenko 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.
- Results publication: PubMed 24491689Ambrosy 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.
- Results publication: PubMed 18279771Cotter 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.
- Results publication: PubMed 27436837Miller 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.
- Results publication: PubMed 30309456Uduman J. Epidemiology of Cardiorenal Syndrome. Adv Chronic Kidney Dis. 2018 Sep;25(5):391-399. doi: 10.1053/j.ackd.2018.08.009.
- Results publication: PubMed 36073644Miller 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.
- Results publication: PubMed 610440Rengstorff RH. Astigmatism after contact lens wear. Am J Optom Physiol Opt. 1977 Nov;54(11):787-91. doi: 10.1097/00006324-197711000-00008.
- Results publication: PubMed 12094185Neuberg 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.
- Results publication: PubMed 35198282Shams 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.
- Results publication: PubMed 34266581Itkin 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.
- Results publication: PubMed 34210416Fudim 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.
- Results publication: PubMed 34869952Martens 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphatic Decompression in people with Cardiovascular Diseases and Chronic Heart Failure, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: During 180 days after the procedure +/- 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06554912, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.