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 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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Diastolic Heart Failure; Heart Failure With Normal Ejection Fraction

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • VA Medical Center
    • Birmingham, Alabama, United States, 35294
      • UAB Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for cardiac catheterization.

Description

Inclusion Criteria:

Major inclusion criteria: Normal screening LV ejection fraction.

Exclusion Criteria:

1. Atrial fibrillation or other significant cardiac arrhythmia on ECG
2. Presence of pacemaker or defibrillator
3. Angioplasty or primary coronary intervention PCI/PTCA during index cardiac catheterization.
4. Patient is unable to undergo cardiac MRI due to contraindication to MRI (MRI incompatible metal prosthesis or implants or significant claustrophobia).
5. Patient taking phosphodiesterase 5 inhibitor (eg. sildenafil) will be excluded due to potential interaction with nitroglycerin.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Diastolic Function; Patients scheduled for cardiac catheterization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To show that torsional hysteresis relates to invasive hemodynamic measure of diastolic function	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).	one time at enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate that torsional hysteresis is a relatively load independent measure of global diastolic function	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.	one time at enrollment
To evaluate the sensitivity and specificity of torsional hysteresis in diagnosing diastolic dysfunction	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	one time at enrollment

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: August 3, 2011
• First Submitted That Met QC Criteria: September 8, 2011
• First Posted (Estimate): September 9, 2011

Study Record Updates

• Last Update Posted (Estimate): August 18, 2015
• Last Update Submitted That Met QC Criteria: August 15, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Heart Failure; Diastolic Heart Failure; Heart Failure with Normal Ejection Fraction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Diastolic
• Other Study ID Numbers: F101215002; 5R01HL104018 (U.S. NIH Grant/Contract)