Mechanisms of Improvement With Beta-Blocker Treatment in Heart Failure

Status Completed

Clinical Trial 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.

Clinical Trial 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 (i.e. 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01261065
Study type	Interventional
Source	Michael Debakey Veterans Affairs Medical Center
Contact
Status	Completed
Phase	Phase 4
Start date	December 2001
Completion date	October 2005

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.