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

Heart Failure Clinical Trial

— rEPORt  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753553
• Other study ID #: 108/int/2019
• Status: Recruiting
• Start date: March 2, 2021
• Est. completion date: July 2025

Study information

• Verified date: March 2023
• Source: IRCCS Policlinico S. Donato
• Contact: Francesco Bandera, MD, PhD
• Phone: (+39) 025277
• Email: Francesco.Bandera[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria di Bari	Bari
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	predictors of HFpEF	to explore the standard (2D and Doppler data) and advanced (LV and LA strain) echocardiographic parameters associated with and potentially predictors of HFpEF.	baseline
Secondary	predictors of HFpEF	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