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Clinical Trials/NCT01714752
NCT01714752
Completed
Not Applicable

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

French Cardiology Society1 site in 1 country60 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure With Preserved Ejection Fraction (HFPEF)
Sponsor
French Cardiology Society
Enrollment
60
Locations
1
Primary Endpoint
E/Ea ratio
Status
Completed
Last Updated
12 years ago

Overview

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 Description

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 analyzed in a second time still blinded to the catheterization data. The following echocardiographic parameters will be collected and compared to the invasive measurement of LVEDP: * Ratio between pulsed Doppler peak E velocity and peak Ea velocity obtained with tissue Doppler imaging (E/Ea ratio) at rest and exercise, * maximal LA volume indexed to body area * (maximal LA volume) to (maximal LV volume) ratio. * LA distensibility defined by: (maximal LA volume - minimal LA volume) / (minimal LA volume) * LA Global longitudinal strain Finally, it will be investigated whether the combined use of E/Ea ratio at exercise with LA remodeling indices (of morphology and/or function) improves the performance characteristics of diagnostic test, compared to a separate use of these parameters.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
September 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
French Cardiology Society
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients hospitalized for coronary angiography
  • Sinus Rhythm
  • Left ventricular Ejection Fraction \> 50%

Exclusion Criteria

  • Age \< 18years
  • Hypertrophic Cardiomyopathy
  • Cardiac transplantation
  • Mitral stenosis
  • Mitral insufficiency \>2/4
  • Severe calcification of mitral annulus
  • Mitral prothesis or mitral repair
  • aortic prothesis
  • Severe aortic stenosis
  • Atrial fibrillation

Outcomes

Primary Outcomes

E/Ea ratio

Time Frame: Day 1

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

Secondary Outcomes

  • left atrial (LA) morphology(Day 1)
  • LA function at rest(Day 1)
  • E/Ea ratio at exercise with LA remodeling indices at rest(Day 1)

Study Sites (1)

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