Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction

Study Overview
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Brief Summary
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The purpose of this study is to examine electrical and echocardiographic characteristics and prognosis of consecutive patients admitted with acute heart failure and diagnosed to have heart failure with preserved ejection fraction (HFPEF).

Detailed Description
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Time 0: Patients will be screened at the time of presentation to the hospital at participating centres Usually patients will be hospitalised for an acute dyspnea in relation with a pulmonary congestion. This congestion does not necessarily justify a hospitalization and for part of the patients a consultation and a dedicated treatment would be good enough to cure the symptoms. Thus, patients seen in emergency for a congestion and diagnosed or known to have a preserved left ventricular ejection fraction (LV EF > 45%) will be proposed to participate to the study. Patients meeting inclusion criteria will be invited back to the clinic in stable condition, approximately 4-8 weeks after the initial hospitalization. Time 4-8 weeks after initial hospitalisation (NOT after discharge): Comprehensive history-taking and examinations. Any information necessary for the study will be collected by the principal investigator in each participating center in a dedicated, secure, e-CRF. The access to the e-CRF will be restrictive to the only principal investigator of each center. The lonely other persons able to take look to the e-CRF are the study monitors. Time 6, 12, and 18 months: Follow up by phone call or review of charts or other records such as death registries. This part of the study will be performed by the CRAs in the French Society of Cardiology

Official Title
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Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction: Prevalence, Characterisation and Prognostic Significance of Cardiac Desynchrony

Conditions
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Congestive Heart Failure, Left Ventricular Ejection Fraction, Heart Failure With Preserved Ejection Fraction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient presenting to the hospital with congestive heart failure, defined as: Clinical signs of heart failure Major criteria Paroxysmal nocturnal dyspnea Orthopnea Jugular venous distension Pulmonary crackling rales 3rd heart sound Cardiothoracic ratio > 0.5 on X-ray Pulmonary oedema on X-ray Minor Criteria peripheral oedema nocturnal cough dyspnoea at exercise hepatomegaly pleural effusion tachycardia (defined as ≥ 100 beats per minute) Heart failure if: presence of 2 major criteria or 1 major + 2 minor criteria LVEF ≥ 45% by echocardiography within 72h BNP > 100 ng/L or NT-proBNP > 300 ng/L Exclusion Criteria: Evidence of primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease Known cause of right heart failure not related to left ventricular dysfunction Pericardial constriction Clinically significant pulmonary disease, as evidenced by requirement of home oxygen. End-stage renal disease requiring dialysis Bi-ventricular pacemaker (CRT)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with HF<br>Each patient seen in hospital emergency or for congestive heart failure and with an ejection fraction above 45% | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death rate | Analyse survival (all-cause death) | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization for HF | Hospitalization for Heart Failure | 18 months | 
| Cardiovascular death | Cardiovascular death | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Ejection Fraction, Echocardiography