Clinical Trial: Evaluation of Left Ventricular Filling Pressures During Exercise

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Left Ventricular Filling Pressures During Exercise: Comparative Study, Catheterization Versus Echocardiography

Brief Summary:

Heart failure with preserved ejection fraction (HFPEF) is common and is a real public health issue. Diagnosis, especially when there are no congestive signs, is difficult. It has been shown that many patients with suspected HFPEF had left ventricular (LV) filling pressures elevated only at exercise (normal at rest).

Using stress echocardiography and taking into account left atrial (LA) remodeling at rest as a "memory" of chronic elevation of filling pressures. We believe that it is possible to improve the noninvasive diagnosis of exercise elevation of the LV end-diastolic pressure (LVEDP).


Detailed Summary:

Purpose Heart failure with preserved ejection fraction (HFPEF) is common and is a real public health issue. Diagnosis, especially when there are no congestive signs, is difficult. It has been shown that many patients with suspected HFPEF had left ventricular (LV) filling pressures elevated only at exercise (normal at rest).

Hypothesis Using stress echocardiography and taking into account left atrial (LA) remodeling at rest as a "memory" of chronic elevation of filling pressures. We believe that it is possible to improve the noninvasive diagnosis of exercise elevation of the LV end-diastolic pressure (LVEDP).

Methods Prospective, monocentric and comparative study: catheterization versus echocardiography.

60 patients referred for coronary angiography will be recruited consecutively during their hospitalization.

Patients should perform a low intensity and short duration exercise, in both catheterization and echo labs (pedaling 3 minutes at 25Watts then, 3 minutes at 50W) The LVEDP will be measured invasively with a pigtail, at rest and at both levels of exercise.

Echocardiography will be performed within 24 hours after catheterization, after a full examination at rest, an identical exercise (same intensity, same duration, same position of the patient) than made in catheterization lab will be done. Following parameters will be recorded at both stress levels: trans mitral flow, mitral annular pulsed tissue Doppler imaging (both lateral and septal) and tricuspid regurgitation flow.

The doctor who will perform the echocardiographic acquisitions will not be informed of the results of catheterization. The acquisitions will be
Sponsor: French Cardiology Society

Current Primary Outcome: E/Ea ratio [ Time Frame: Day 1 ]

E/Ea ratio as a non-invasive index of Left Ventricular and diastolic pressure (LVEDP) at exercise


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • left atrial (LA) morphology [ Time Frame: Day 1 ]
    To evaluate left atrial (LA) morphology at rest (maximal LA volume indexed to body area, maximal LA volume to maximal LV volume ratio) as an index of Left Ventricular end diastolic pressure (LVEDP) at exercise.
  • LA function at rest [ Time Frame: Day 1 ]
    To evaluate LA function at rest (distensibility, global longitudinal strain) as an index of Left Ventricular end diastolic pressure (LVEDP) at exercise.
  • E/Ea ratio at exercise with LA remodeling indices at rest [ Time Frame: Day 1 ]
    To investigate whether the combined use of E/Ea ratio at exercise with LA remodeling indices at rest (of morphology and/or function) improves the performance characteristics of diagnostic test compared to a separate use of these parameters.


Original Secondary Outcome: Same as current

Information By: French Cardiology Society

Dates:
Date Received: October 19, 2012
Date Started: December 2012
Date Completion:
Last Updated: September 27, 2013
Last Verified: September 2013