Evaluation of Left Ventricular Filling Pressures During Exercise

Heart Failure With Preserved Ejection Fraction (HFPEF) Clinical Trial

— PREFFORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714752
• Other study ID #: 2012-02
• Status: Completed
• Phase: N/A
• First received: October 19, 2012
• Last updated: September 27, 2013
• Start date: December 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité des Médicaments
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure With Preserved Ejection Fraction (HFPEF)
• Left Ventricular End Diastolic Pressure (LVEDP)

Intervention

Procedure:
• measure of left ventricular and diastolic pressure at exercise

Locations

Country	Name	City	State
France	Pitié Salpêtrière Hospital - Cardiology Department	Paris

Sponsors (2)

Lead Sponsor	Collaborator
French Cardiology Society	French Federation of Cardiology

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	E/Ea ratio	E/Ea ratio as a non-invasive index of Left Ventricular and diastolic pressure (LVEDP) at exercise	Day 1	No
Secondary	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.	Day 1	No
Secondary	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.	Day 1	No
Secondary	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.	Day 1	No