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NCT01431027 · ClinicalTrials.gov registry record
Left Ventricular Torsional Hysteresis: A Global Parameter for Diastolic Function
A clinical trial, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- 45
- Enrollment target
NCT01431027: Completed study, sponsored by University of Alabama at Birmingham.
NCT01431027 is a clinical trial that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01431027 has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2011-08 |
| Est. Completion | 2015-06 |
What the finished NCT01431027 record still lists
NCT01431027 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01431027 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01431027 about?
NCT01431027 is a clinical study titled "Left Ventricular Torsional Hysteresis: A Global Parameter for Diastolic Function". 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 symptomat...
What is the current status of trial NCT01431027?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2011-08. Estimated completion is 2015-06.
Who is sponsoring clinical trial NCT01431027?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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