Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554912
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-04-25
Brief Title:
FLOWS-HF Feasibility of Lymphatic Offloading With Stenting in Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Safety and Feasibility of Lymphatic Decompression in Chronic Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLOW-HF
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
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 systems 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None