Left Ventricular Torsional Hysteresis: A Global Parameter for Diastolic Function
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01431027|
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : August 18, 2015
Diastolic dysfunction refers to abnormal mechanical properties of the myocardium and includes abnormal LV diastolic distensibility, impaired filling and slow or delayed relaxation- regardless of whether the ejection fraction is normal or depressed and whether the patient is asymptomatic or symptomatic. Epidemiologic studies have demonstrated high prevalence of diastolic heart failure (DHF). The quality of life of these patients is impaired and the clinical outcomes are similar to those with heart failure with systolic dysfunction. Therefore diastolic dysfunction has significant adverse economic impact that is expected to grow further with time. Clinical characteristics alone may not be sufficient to diagnose diastolic dysfunction. A number of invasive and non-invasive parameters have been proposed to diagnose diastolic dysfunction. Most of the presently used non-invasive parameters have a number of limitations. High fidelity measurement of the left ventricular pressures is needed to accurately diagnose diastolic dysfunction. Obtaining it in routine clinical practice is impractical.
In this protocol the investigators have proposed a novel non-invasive parameter called 'Torsional Hysteresis' as a measure of diastolic function. This will be measured using non-invasive cardiac MRI technique. During left ventricular contraction and relaxation, myocardium deforms. During cardiac cycle the myocardium goes back to baseline state prior to beginning of each contraction. However the rate with which it returns to the baseline state is variable. Torsion indicates relative wringing motion of the ventricle around a left ventricular axis and is a global parameter of left ventricular deformation. The parameters have defined a new parameter called torsional hysteresis based on non invasive cardiac MRI assessment. The parameters have hypothesized that for diastolic dysfunction, the torsional hysteresis area is increased as compared to no diastolic dysfunction group.
|Condition or disease|
|Heart Failure Diastolic Heart Failure Heart Failure With Normal Ejection Fraction|
|Study Type :||Observational|
|Actual Enrollment :||45 participants|
|Official Title:||Left Ventricular Torsional Hysteresis: A Global Parameter for Diastolic Function|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Patients scheduled for cardiac catheterization.
- To show that torsional hysteresis relates to invasive hemodynamic measure of diastolic function [ Time Frame: one time at enrollment ]To show that torsional hysteresis relates to invasive hemodynamic measure of diastolic function: a) Exponential fall of pressure during isovolumic relaxation phase by the time constant of relaxation, tau and b) LV end diastolic pressure-volume relationship (EDPVR).
- To demonstrate that torsional hysteresis is a relatively load independent measure of global diastolic function [ Time Frame: one time at enrollment ]To demonstrate that torsional hysteresis is a relatively load independent measure of global diastolic function by evaluating effects of nitroglycerin (NTG) on torsional hysteresis and correlating it to invasive hemodynamic measure of diastolic function including a) tau and b) EDPVR.
- To evaluate the sensitivity and specificity of torsional hysteresis in diagnosing diastolic dysfunction [ Time Frame: one time at enrollment ]To evaluate the sensitivity and specificity of torsional hysteresis in diagnosing diastolic dysfunction (as defined by invasive hemodynamic parameters: tau, EDPVR) and compare it to echocardiographic tissue Doppler assessment in patients undergoing cardiac catheterization for suspected diastolic dysfunction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431027
|United States, Alabama|
|VA Medical Center|
|Birmingham, Alabama, United States, 35243|
|Birmingham, Alabama, United States, 35294|