Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510322
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Contemporary left ventricular assist device LVAD therapy improves survival during advanced heart failure but vascular aging develops rapidly leading to major adverse events including stroke and bleeding in nearly half of patients In this study the study team aims to investigate whether sildenafil pharmacotherapy which has anti-fibrotic effects can reduce vascular aging during LVAD support
Detailed Description:
Over 65 million individuals in the United States suffer from heart failure HF with the burden of this disease expected to grow over the next decade Approximately 300000 of these patients have advanced HF and may benefit from durable left ventricular assist device LVAD therapy which can improve outcomes during advanced HF However despite advancements in device design that have increased survival rates large registries of real- world cases reveal that nearly half of patients experience severe vascular adverse events including stroke and bleeding during prolonged contemporary LVAD support This elevated adverse-event rate remains a major barrier to safely expanding the use and durability of LVAD therapy Vascular remodeling or aging of the large and small blood vessels is known to promote stroke and bleeding within the general population Critically such remodeling is rapidly accelerated under conditions of reduced pulsatility produced by LVADs evidenced by large vessel stiffening and fibrosis small vessel angiodysplasia and endothelial dysfunction Phosphodiesterase-5 inhibitors PDE5i such as sildenafil are prescribed to select LVAD patients with pulmonary hypertension and right heart failure However given that these agents enhance nitric oxide-cGMP signaling in platelets and vascular smooth muscle cells leading to anti-thrombotic and anti-fibrotic effects they may also reduce vascular remodeling and related adverse events Here based on preliminary findings a double-blind randomized placebo-controlled trial will be conducted to determine the effects of chronic sildenafil administration on vascular remodeling during LVAD support
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