Significance of Regional Ventriculo-arterial Coupling in Patients With Chronic Heart Failure
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Significance of Regional Ventriculo-arterial Coupling in Patients With Chronic Heart Failure: Effects of Endothelial Progenitor Cells and a Direct Renin Inhibitor|
- CV mortality and HF re-admission [ Time Frame: 1 year after enrollment ] [ Designated as safety issue: No ]
- Ventricular function [ Time Frame: 1 year after enrollment ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: placebo
Aliskiren 150 mh
Heart failure is a major health problem worldwide. Optimal treatment of this disabling and fatal condition may require functional characterization of the failed left ventricle (LV) and its interaction with the arterial system. Part of the physiological significance of the ventriculo-arterial coupling has been studied experimentally and clinically using the framework of the ratio of effective arterial elastance (Ea) to end-systolic elastance (Ees), with limited clinical applications.
From central ascending aorta to terminal arterioles, every segment of the arterial tree contributes to the arterial loads that interact and impact LV performance in both systole and diastole, leads to atrial and ventricular remodeling and hypertrophy, and results in the development of heart failure. On the other hand, the ventricular systole is a complex coordination of multi-directional myocardial fibers involving longitudinal contraction, circumferential shortening, radial thickening, twist, and torsion, the so-called LV deformations.
In the proposed 3-year project, the investigators hypothesize that the different components of arterial load are coupled with different components of LV function. The regional ventriculo-arterial couplings may be important in the pathogenesis of heart failure and ventricular remodeling, and in the prediction of future cardiovascular events. Therapies targeting these may play a role in the prevention and treatment of heart failure. Therefore, the investigators will study at least 60 patients with chronic heart failure (NYHA Class II-IV) who will randomly receive a direct renin inhibitor, aliskiren, or a placebo for 6 months on top of standard therapy. The purposes of the present study are to investigate the relationship between different components of hemodynamic load or arterial abnormalities and different components of LV myocardial deformations or regional LV function, the modulating effects of endothelial progenitor cells (EPCs) on the ventriculo-arterial coupling, and the therapeutic effects of aliskiren on the components of hemodynamic load and LV myocardial deformations and their couplings. The investigators will also investigate whether the ventriculo-arterial coupling, EPCs, and add-on therapy of aliskiren predict cardiovascular outcomes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298258
|Taipei Veterans General Hospital|
|Principal Investigator:||Chen-Huan chen, M.D.||Taipei Veterans General Hospital, Taiwan|