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

NCT05753553 | Unknown DMC

• 1 other identifier: 108/int/2019
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 6

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

Conditions

Heart Failure; Heart Failure With Preserved Ejection Fraction

Keywords

Echocardiographic Predictors; Heart Failure with Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• incidence of HFpEF

  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 Outcomes (2)

• predictors of HFpEF

  baseline

• predictors of HFpEF

  after 12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (6)

Azienda Ospedaliero-Universitaria di Bari

Bari, Italy

RECRUITING

IRCCS Policlinico San Donato

Milan, 20097, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

RECRUITING

AUSL Romagna

Ravenna, Italy

RECRUITING

Università degli Studi di Siena

Siena, Italy

RECRUITING

Università degli studi di Verona

Verona, Italy

RECRUITING

Related Publications (2)

• Dunlay SM, Roger VL, Redfield MM. Epidemiology of heart failure with preserved ejection fraction. Nat Rev Cardiol. 2017 Oct;14(10):591-602. doi: 10.1038/nrcardio.2017.65. Epub 2017 May 11.

  PMID: 28492288 BACKGROUND

• Gerber Y, Weston SA, Redfield MM, Chamberlain AM, Manemann SM, Jiang R, Killian JM, Roger VL. A contemporary appraisal of the heart failure epidemic in Olmsted County, Minnesota, 2000 to 2010. JAMA Intern Med. 2015 Jun;175(6):996-1004. doi: 10.1001/jamainternmed.2015.0924.

  PMID: 25895156 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Francesco Bandera, MD, PhD

  university cardiology department, IRCCS Policlinico San Donato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Bandera, MD, PhD

CONTACT

(+39) 025277; Francesco.Bandera@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 3, 2023
• Study Start: March 2, 2021
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

IT (6)