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Clinical Trials/NCT05753553
NCT05753553
Recruiting
Not Applicable

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

IRCCS Policlinico S. Donato6 sites in 1 country1,000 target enrollmentMarch 2, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
IRCCS Policlinico S. Donato
Enrollment
1000
Locations
6
Primary Endpoint
incidence of HFpEF
Status
Recruiting
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 2, 2021
End Date
July 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
IRCCS Policlinico S. Donato
Responsible Party
Principal Investigator
Principal Investigator

Francesco Bandera

Principal Investigator

IRCCS Policlinico S. Donato

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%

Outcomes

Primary Outcomes

incidence of HFpEF

Time Frame: 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 Outcomes

  • predictors of HFpEF(after 12 months)

Study Sites (6)

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