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Evaluation of Left Ventricular Filling Pressures During Exercise (PREFFORT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01714752
First Posted: October 26, 2012
Last Update Posted: September 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
French Federation of Cardiology
Information provided by (Responsible Party):
French Cardiology Society
  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).

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).


Condition Intervention
Heart Failure With Preserved Ejection Fraction (HFPEF) Left Ventricular End Diastolic Pressure (LVEDP) Procedure: measure of left ventricular and diastolic pressure at exercise

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Left Ventricular Filling Pressures During Exercise: Comparative Study, Catheterization Versus Echocardiography

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise
Patients perform exercise and pression measure is performed
Procedure: measure of left ventricular and diastolic pressure at exercise

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Acute coronary syndrom < 3 months
  • Left ventricular thrombus
  • Severe renal Failure
  • failure of radial way for coronary angiography
  • coronary lesion indicating an angioplasty
  • impossibility to perform an exercise
  • refusal or inability to sign informed consent
  • no French medical insurance
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714752


Locations
France
Pitié Salpêtrière Hospital - Cardiology Department
Paris, France, 75013
Sponsors and Collaborators
French Cardiology Society
French Federation of Cardiology
Investigators
Principal Investigator: Nadjib Hammoudi, MD Cardiology department - Pitié Salpêtrière Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT01714752     History of Changes
Other Study ID Numbers: 2012-02
First Submitted: October 19, 2012
First Posted: October 26, 2012
Last Update Posted: September 30, 2013
Last Verified: September 2013

Keywords provided by French Cardiology Society:
Diagnosis
Left ventricular end diastolic pressure (LVEDP)
Exercise echocardiography
Left atrial remodeling

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases