Incidence and Echocardiographic Predictors of HFpEF in High-Risk Population Afferent to Italian Echo-labs Network

Study Overview
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Brief Summary
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The evolving definitions of HF, the increasing attention of the medical community, and the aging of the population are some of the factors contributing to a still debated incidence and prevalence of HFpEF across the general and specific populations. Despite the current decline in new HF cases, HFpEF shows stable incidence according to epidemiological studies. Cardiovascular risk factors, such as a long history of hypertension, diabetes, obesity, and others seem to be associated with a higher HFpEFincidence. Nevertheless, the potential echocardiographic predictors of HFpEF have not been defined yet. Hypothesis In a population at high risk for HFpEF, collected using a multicenter echo-lab network, the real incidence of HFpEF cases and echocardiographic predictors can be identified. Aim 1: to define the incidence of HFpEF in a high-risk cohort of patients afferent to the Italian echo-lab network. Aim 2: to explore the standard (2D and Doppler data) and advanced (LV and LA strain) echocardiographic parameters associated with and potential predictors of HFpEF. Methods This is a multicenter, prospective, observational study involving an Italian echo labs network. According to inclusion and exclusion criteria, patients will be enrolled during standard echocardiographic evaluation. After signing informed consent, clinical and echocardiographic data will be collected. Thereafter, they will be followed up for major clinical events (cardiovascular death, HF requiring hospitalization, myocardial infarct, and atrial fibrillation) for a period of 12 months

Official Title
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Incidence and Echocardiographic Predictors of HFpEF in High-Risk Population Afferent to Italian Echo-labs Network

Conditions
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Heart Failure, Heart Failure With Preserved Ejection Fraction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >65 years Echocardiographic LV EF >50% Diastolic dysfunction at echocardiography of at least grade 1 LV hypertrophy defined as: linear LV mass >115 in men, >95 g/m2 in women Left atrium (LA) enlargement defined as LA volume > 34 mL/ m2 Exclusion Criteria: Severe chronic renal failure (GFR <15) Severe chronic obstructive pulmonary disease (COPD) (FEV1 <1) More than moderate valve disease Previous cardiac surgery Previous LV EF <40%

Ages Eligible for Study
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Minimum Age: 65 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 |
| --- | --- |
| Heart Failure with preserved Ejection Fraction (HFpEF)<br>After signing informed consent, clinical and echocardiographic data will be collected. Thereafter, they will be followed up for major clinical events (cardiovascular death, HF requiring hospitalization, myocardial infarction, and atrial fibrillation) for a period of 12 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of HFpEF | to define the incidence of HFpEF in a high-risk cohort of patients afferent to Italian echo-lab network | after 12 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictors of HFpEF | to explore the standard (2D and Doppler data) and advanced (LV and LA strain) echocardiographic parameters associated with and potentially predictors of HFpEF. | baseline | 
| predictors of HFpEF | to explore the standard (2D and Doppler data) and advanced (LV and LA strain) echocardiographic parameters associated with and potentially predictors of HFpEF. | after 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Echocardiographic Predictors, Heart Failure with Preserved Ejection Fraction