Clinical trial NCT05753553: Incidence and Echocardiographic Predictors of HFpEF in High-Risk Population Afferent to Italian Echo-labs Network
Official title: Incidence and Echocardiographic Predictors of HFpEF in High-Risk Population Afferent to Italian Echo-labs Network
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Heart Failure With Preserved Ejection Fraction
Keywords: Echocardiographic Predictors
Heart Failure with Preserved Ejection Fraction
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the population at high risk for Heart Failure with preserved Ejection Fraction, wth the following characteristics:

* Age \>65 years
* 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

Brief summary: 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


Eligibility criteria: 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%

Primary outcomes:
measure: incidence of HFpEF
timeFrame: after 12 months from baseline
Secondary outcomes:
measure: predictors of HFpEF
timeFrame: baseline
measure: predictors of HFpEF
timeFrame: after 12 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bari
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena
city: Ravenna
country: Italy
facility: AUSL Romagna
city: Siena
country: Italy
facility: Università degli Studi di Siena
city: Verona
country: Italy
facility: Università degli studi di Verona
Study officials:
affiliation: university cardiology department, IRCCS Policlinico San Donato
name: Francesco Bandera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunlay SM, Roger VL, Redfield MM. Epidemiology of heart failure with preserved ejection fraction. Nat Rev Cardiol. 2017 Oct;14(10):591-602. doi: 10.1038/nrcardio.2017.65. Epub 2017 May 11.
citation: Gerber Y, Weston SA, Redfield MM, Chamberlain AM, Manemann SM, Jiang R, Killian JM, Roger VL. A contemporary appraisal of the heart failure epidemic in Olmsted County, Minnesota, 2000 to 2010. JAMA Intern Med. 2015 Jun;175(6):996-1004. doi: 10.1001/jamainternmed.2015.0924.