Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00527059
Status:
UNKNOWN
Last Update Posted:
2007-09-10
First Post:
2007-09-07
Brief Title:
Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effect of levosimendan infusion in addition to standard therapyon renal function in patients with Acute Heart Failurecompared with standard therapy alone
Detailed Description:
The term cardiorenal syndrome has been applied to the presence or development of a renal dysfunction in HF patients and may be the major precipitant of decompensation and cause for admission in these patients The renal hypoperfusion that occurs with cardiac injury can lead to sodium and water retention and activation of the renin-angiotensin-aldosterone system and neurohormonal pathways with resultant deleterious effects on the myocardium A vicious cycle may then ensue and be associated with increased cardiovascular complications In this regard renal dysfunction is of a functional nature and thus means to intervene with this vicious cycle need to be sought
Several studies already demonstrated the deleterious effects of renal dysfunction on prognosis in patients with HF due to chronic left ventricular dysfunction
Levosimendan increases myocardial contractility without significant changes in the intracellular calcium ion and cyclic adenosine monophosphate concentrations and does not enhance myocardial oxygen demand By its action on the potassium channels this drug also dilates the coronary and peripheral arteries and exerts an anti-ischemicanti-stunning effect To date the effects of levosimendan on renal function in patients with worsening chronic HF remain unknown
Several studies already demonstrated the deleterious effects of renal dysfunction on prognosis in patients with HF due to chronic left ventricular dysfunction
Levosimendan increases myocardial contractility without significant changes in the intracellular calcium ion and cyclic adenosine monophosphate concentrations and does not enhance myocardial oxygen demand By its action on the potassium channels this drug also dilates the coronary and peripheral arteries and exerts an anti-ischemicanti-stunning effect To date the effects of levosimendan on renal function in patients with worsening chronic HF remain unknown
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