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Left Ventricular Torsional Hysteresis: A Global Parameter for Diastolic Function

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01431027
First received: August 3, 2011
Last updated: April 23, 2014
Last verified: February 2014
  Purpose

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
Heart Failure
Diastolic Heart Failure
Heart Failure With Normal Ejection Fraction

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Left Ventricular Torsional Hysteresis: A Global Parameter for Diastolic Function

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • To show that torsional hysteresis relates to invasive hemodynamic measure of diastolic function [ Time Frame: one time at enrollment ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • To demonstrate that torsional hysteresis is a relatively load independent measure of global diastolic function [ Time Frame: one time at enrollment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 180
Study Start Date: August 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diastolic Function
Patients scheduled for cardiac catheterization.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients scheduled for cardiac catheterization.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431027

Locations
United States, Alabama
UAB Hospital
Birmingham, Alabama, United States, 35294
VA Medical Center
Birmingham, Alabama, United States, 35243
Sponsors and Collaborators
University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01431027     History of Changes
Other Study ID Numbers: F101215002, 5R01HL104018
Study First Received: August 3, 2011
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Heart Failure
Diastolic Heart Failure
Heart Failure with Normal Ejection Fraction

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014