Heart Failure With Preserved Ejection Fraction (HFPEF)PREFFORTNCT01714752
Evaluation of Left Ventricular Filling Pressures During Exercise
A study testing measure of left ventricular and diastolic pressure at exercise in people with Heart Failure With Preserved Ejection Fraction (HFPEF) and Left Ventricular End Diastolic Pressure (LVEDP), run by French Cardiology Society at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFPEF), Left Ventricular End Diastolic Pressure (LVEDP)
- What is being tested?
- measure of left ventricular and diastolic pressure at exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized for coronary angiography
- Sinus Rhythm
- Left ventricular Ejection Fraction > 50%
Who cannot join
- Age < 18years
- Hypertrophic Cardiomyopathy
- Cardiac transplantation
- Mitral stenosis
- Mitral insufficiency >2/4
- Severe calcification of mitral annulus
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Left Ventricular Filling Pressures During Exercise: Comparative Study, Catheterization Versus Echocardiography
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).
Read the 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.
- Conditions
- Heart Failure With Preserved Ejection Fraction (HFPEF), Left Ventricular End Diastolic Pressure (LVEDP)
- Being tested
- measure of left ventricular and diastolic pressure at exercise
- Keywords
- Diagnosis, Left ventricular end diastolic pressure (LVEDP), Exercise echocardiography, Left atrial remodeling
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure of left ventricular and diastolic pressure at exerciseProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | Patients perform exercise and pression measure is performed Receives: Procedure: measure of left ventricular and diastolic pressure at exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
E/Ea ratio
E/Ea ratio as a non-invasive index of Left Ventricular and diastolic pressure (LVEDP) at exercise
Measured: Day 1
Secondary outcomes (3)
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFPEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- French Federation of Cardiology
- Responsible party
- Sponsor
- Investigators
- Nadjib Hammoudi, MD, Principal investigator, Cardiology department - Pitié Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714752
- Sponsor's protocol ID
- 2012-02
- Acronym
- PREFFORT
- Status last verified
- Sep 2013
- First submitted
- 19 Oct 2012
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27695989
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Left Ventricular Filling Pressures During Exercise: Comparative Study, Catheterization Versus Echocardiography
- ClinicalTrials.gov ID
- NCT01714752
- Acronym / sponsor ID
- PREFFORT / 2012-02
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- French Federation of Cardiology
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Procedure: measure of left ventricular and diastolic pressure at exercisePatients perform exercise and pression measure is performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients hospitalized for coronary angiography
- Sinus Rhythm
- Left ventricular Ejection Fraction > 50%
Key exclusion criteria (18 listed)
- Age < 18years
- Hypertrophic Cardiomyopathy
- Cardiac transplantation
- Mitral stenosis
- Mitral insufficiency >2/4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measure of left ventricular and diastolic pressure at exercise | Procedure or surgery | exercise |
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
3 secondary outcomes
left atrial (LA) morphology
Time frame: Day 1
LA function at rest
Time frame: Day 1
E/Ea ratio at exercise with LA remodeling indices at rest
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
- Derived from this study: PubMed 27695989Hammoudi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadjib Hammoudi, MD principal investigator
Cardiology department - Pitié Salpêtrière Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measure of left ventricular and diastolic pressure at exercise in people with Heart Failure With Preserved Ejection Fraction (HFPEF) and Left Ventricular End Diastolic Pressure (LVEDP), run by French Cardiology Society at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
E/Ea ratio (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01714752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2013.