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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05753553
Acronym
rEPORt
Enrollment
1000
Registered
2023-03-03
Start date
2021-03-02
Completion date
2025-07-31
Last updated
2023-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Heart Failure With Preserved Ejection Fraction

Keywords

Echocardiographic Predictors, Heart Failure with Preserved Ejection Fraction

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

Interventions

None listed

Sponsors

IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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%

Design outcomes

Primary

MeasureTime frameDescription
incidence of HFpEFafter 12 months from baselineto define the incidence of HFpEF in a high-risk cohort of patients afferent to Italian echo-lab network

Secondary

MeasureTime frameDescription
predictors of HFpEFbaselineto explore the standard (2D and Doppler data) and advanced (LV and LA strain) echocardiographic parameters associated with and potentially predictors of HFpEF.

Countries

Italy

Contacts

Primary ContactFrancesco Bandera, MD, PhD
Francesco.Bandera@grupposandonato.it(+39) 025277

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026