Evaluation of Left Ventricular Filling Pressures During Exercise (PREFFORT)
Primary Purpose
Heart Failure With Preserved Ejection Fraction (HFPEF), Left Ventricular End Diastolic Pressure (LVEDP)
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
measure of left ventricular and diastolic pressure at exercise
Sponsored by

About this trial
This is an interventional diagnostic trial for Heart Failure With Preserved Ejection Fraction (HFPEF) focused on measuring Diagnosis, Left ventricular end diastolic pressure (LVEDP), Exercise echocardiography, Left atrial remodeling
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
- 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
Sites / Locations
- Pitié Salpêtrière Hospital - Cardiology Department
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
exercise
Arm Description
Patients perform exercise and pression measure is performed
Outcomes
Primary Outcome Measures
E/Ea ratio
E/Ea ratio as a non-invasive index of Left Ventricular and diastolic pressure (LVEDP) at exercise
Secondary Outcome Measures
left atrial (LA) morphology
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
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
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.
Full Information
NCT ID
NCT01714752
First Posted
October 19, 2012
Last Updated
September 27, 2013
Sponsor
French Cardiology Society
Collaborators
French Federation of Cardiology
1. Study Identification
Unique Protocol Identification Number
NCT01714752
Brief Title
Evaluation of Left Ventricular Filling Pressures During Exercise
Acronym
PREFFORT
Official Title
Evaluation of Left Ventricular Filling Pressures During Exercise: Comparative Study, Catheterization Versus Echocardiography
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
Collaborators
French Federation of Cardiology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction (HFPEF), Left Ventricular End Diastolic Pressure (LVEDP)
Keywords
Diagnosis, Left ventricular end diastolic pressure (LVEDP), Exercise echocardiography, Left atrial remodeling
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise
Arm Type
Experimental
Arm Description
Patients perform exercise and pression measure is performed
Intervention Type
Procedure
Intervention Name(s)
measure of left ventricular and diastolic pressure at exercise
Primary Outcome Measure Information:
Title
E/Ea ratio
Description
E/Ea ratio as a non-invasive index of Left Ventricular and diastolic pressure (LVEDP) at exercise
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
left atrial (LA) morphology
Description
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.
Time Frame
Day 1
Title
LA function at rest
Description
To evaluate LA function at rest (distensibility, global longitudinal strain) as an index of Left Ventricular end diastolic pressure (LVEDP) at exercise.
Time Frame
Day 1
Title
E/Ea ratio at exercise with LA remodeling indices at rest
Description
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.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadjib Hammoudi, MD
Organizational Affiliation
Cardiology department - Pitié Salpêtrière Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pitié Salpêtrière Hospital - Cardiology Department
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27695989
Citation
Hammoudi N, Laveau F, Helft G, Cozic N, Barthelemy O, Ceccaldi A, Petroni T, Berman E, Komajda M, Michel PL, Mallet A, Le Feuvre C, Isnard R. Low level exercise echocardiography helps diagnose early stage heart failure with preserved ejection fraction: a study of echocardiography versus catheterization. Clin Res Cardiol. 2017 Mar;106(3):192-201. doi: 10.1007/s00392-016-1039-0. Epub 2016 Sep 30.
Results Reference
derived
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Evaluation of Left Ventricular Filling Pressures During Exercise
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