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

March 2, 2023 updated by: Francesco Bandera, IRCCS Policlinico S. Donato

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Heart Failure with preserved Ejection Fraction (HFpEF)
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 infarction, and atrial fibrillation) for a period of 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 12 months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
predictors of HFpEF
Time Frame: baseline
to explore the standard (2D and Doppler data) and advanced (LV and LA strain) echocardiographic parameters associated with and potentially predictors of HFpEF.
baseline
predictors of HFpEF
Time Frame: 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.
after 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Investigators

  • Principal Investigator: Francesco Bandera, MD, PhD, university cardiology department, IRCCS Policlinico San Donato

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2021

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108/int/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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