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

Recruiting

• Conditions: Heart Failure; Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT05753553
• Lead Sponsor: IRCCS Policlinico S. Donato

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-02
• Study First Submitted: 2023-02-17
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-02
• Last Update Submitted: 2023-03-02
• Study First Posted: 2023-03-03
• Last Update Posted: 2023-03-03
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of HFpEF	after 12 months from baseline	to define the incidence of HFpEF in a high-risk cohort of patients afferent to Italian echo-lab network

Secondary Outcome Measures

Name	Time	Method
predictors of HFpEF	after 12 months	to explore the standard (2D and Doppler data) and advanced (LV and LA strain) echocardiographic parameters associated with and potentially predictors of HFpEF.

Trial Locations

Locations (6)

IRCCS Policlinico San Donato; 🇮🇹 Milan, Italy

Azienda Ospedaliero-Universitaria di Modena; 🇮🇹 Modena, Italy

AUSL Romagna; 🇮🇹 Ravenna, Italy

Università degli Studi di Siena; 🇮🇹 Siena, Italy

Università degli studi di Verona; 🇮🇹 Verona, Italy

Azienda Ospedaliero-Universitaria di Bari; 🇮🇹 Bari, Italy