Ignite Creation Date:
2024-05-06 @ 9:52 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03091998
Status:
WITHDRAWN
Last Update Posted:
2017-07-28
First Post:
2017-03-09
Brief Title:
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase I Trial to Determine Safety and Efficacy of Chronic Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
Status:
WITHDRAWN
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No funding available
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CD-NPLVAD
Brief Summary:
The worldwide use of left ventricular assist devices LVAD which is mechanical device to improve hemodynamic function has improved the outcomes of severe heart failure HF patients leading to the continued annual increase in the number of LVAD implantations However LVAD support still results in major complications such as renal failure or gastrointestinal bleeding The investigators hypothesize that such major complications may be due to endothelial dysfunction induced by the lack of pulsatility which may be improved by an innovative designer natriuretic peptide CD-NP They have demonstrated its favorable actions in animal models as well as humans and tested its safety in LVAD patients They hypothesize that CD-NP will have renal and endothelial protective actions through its receptor GC-A and GC-B Thus the investigators will test their hypothesis with a highly translational approach to examine CD-NPs role in endothelial and renal protection
The aim is to determine safety and tolerability together with cGMP activating neurohumoral modulating and renovascular protective properties of chronic subcutaneous delivery of CD-NP compared to placebo in stable LVAD patients for 3 days
The aim is to determine safety and tolerability together with cGMP activating neurohumoral modulating and renovascular protective properties of chronic subcutaneous delivery of CD-NP compared to placebo in stable LVAD patients for 3 days
Detailed Description:
Stable patients with LVAD implantation 3 months sp implantation will undergo 3-day testing in the Mayo Clinics Clinical Research and Trials Unit They will undergo daily subcutaneous injection of CD-NP or placebo for 3 days with hemodynamic monitoring ECHO endothelial function assessment and renal blood flow monitoring Blood and urine samples will also be collected and assayed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None