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ClinicalTrials.gov ID

NCT05753553

Lead Sponsor

IRCCS Policlinico S. DonatoOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

1,000Estimated

Last Update Posted

Mar 3, 2023Actual

Start Date

Mar 2, 2021Actual

Primary Completion Date

Jun 2025Estimated

Completion Date

Jul 2025Estimated

Official Title

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

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

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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%

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

IRCCS Policlinico S. DonatoOTHER

matteo.lisi@hotmail.it