Evaluation of Left Ventricular Filling Pressures During Exercise
PREFFORT
1 other identifier
interventional
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2012
CompletedFirst Posted
Study publicly available on registry
October 26, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedSeptember 30, 2013
September 1, 2013
9 months
October 19, 2012
September 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
E/Ea ratio
E/Ea ratio as a non-invasive index of Left Ventricular and diastolic pressure (LVEDP) at exercise
Day 1
Secondary Outcomes (3)
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 Arms (1)
exercise
EXPERIMENTALPatients perform exercise and pression measure is performed
Interventions
Eligibility Criteria
You may qualify if:
- Patients hospitalized for coronary angiography
- Sinus Rhythm
- Left ventricular Ejection Fraction \> 50%
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- French Cardiology Societylead
- French Federation of Cardiologycollaborator
Study Sites (1)
Pitié Salpêtrière Hospital - Cardiology Department
Paris, 75013, France
Related Publications (1)
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.
PMID: 27695989DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadjib Hammoudi, MD
Cardiology department - Pitié Salpêtrière Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2012
First Posted
October 26, 2012
Study Start
December 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
September 30, 2013
Record last verified: 2013-09