Ignite Creation Date:
2024-05-05 @ 11:09 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01261065
Status:
COMPLETED
Last Update Posted:
2010-12-16
First Post:
2010-12-15
Brief Title:
Mechanisms of Improvement With Beta-Blocker Treatment in Heart Failure
Sponsor:
Michael E DeBakey VA Medical Center
Organization:
Michael E DeBakey VA Medical Center
Study Overview
Official Title:
Mechanisms of Improvement With Beta-Blocker Treatment in Heart Failure
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
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 overall hypothesis of this application is that the improvement in LV ejection performance following treatment with betablockers is due at least in part to improvement in intrinsic myocardial contractility
Detailed Description:
The immediate specific objectives of this application are two-fold 1 to determine whether the observed improvement in LV ejection performance is due to alterations in intrinsic cardiac myocardial contractility and 2 to determine whether changes in LV contractile reserve following an infusion of intravenous milrinone can be used to predict a salutary response to beta-blockers The immediate specific objectives of this proposal will be addressed in the following two Specific Aims In Specific Aim 1 we will determine whether the observed improvement in LV ejection fraction following treatment with beta-blockers is due to changes in intrinsic myocardial contractility as opposed to changes in LV remodeling ie reduction in LV volume or changes in LV loading conditions Changes in LV function will be evaluated using proven indexes one an ejection phase index the relation of end-systolic stress ESS to the mean velocity of fiber shortening VCF considered a relatively load independent measure of contractility Changes in LV structure will be evaluated using echocardiography In Specific Aim 2 we will determine whether the salutary response to beta-blockers can be predicted by measuring contractile reserve defined as a change in contractility determined by the relation of the mean velocity of fiber shortening VCF to end-systolic stress ESS in response to intravenous milrinone infusion at the cardiac catheterization lab prior to the institution of beta-blockade The response to treatment with beta-blockers will be assessed by measurement of LV ejection fraction and LV end-diastolic volume by echocardiography after 6 months of treatment with beta-blockers and these measurements will be correlated with the respective changes in contractile reserve measurement at baseline
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