Identifying heart failure with preserved ejection fraction in high-risk patients in Italy
Incidence and Echocardiographic Predictors of HFpEF in High-Risk Population Afferent to Italian Echo-labs Network
This study looks at how common heart failure with preserved ejection fraction is among older patients at high risk in Italy and what tests can help identify it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 6 sites (Bari and 5 other locations) |
| Trial ID | NCT05753553 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the incidence of heart failure with preserved ejection fraction (HFpEF) in a high-risk population using a multicenter echocardiographic network in Italy. It will explore both standard and advanced echocardiographic predictors of HFpEF, focusing on patients over 65 years with specific echocardiographic criteria. By analyzing data from various echo-labs, the study seeks to provide insights into the prevalence and predictors of HFpEF, which remains a significant concern in cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 65 years old with echocardiographic evidence of diastolic dysfunction and preserved left ventricular ejection fraction.
Not a fit: Patients with severe chronic renal failure, severe COPD, significant valve disease, or a history of cardiac surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection and management strategies for heart failure with preserved ejection fraction in at-risk populations.
How similar studies have performed: While the study addresses a well-recognized issue in cardiovascular health, the specific approach of utilizing a multicenter echo-lab network to identify HFpEF incidence and predictors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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%
Where this trial is running
Bari and 5 other locations
- Azienda Ospedaliero-Universitaria di Bari — Bari, Italy (Recruiting)
- IRCCS Policlinico San Donato — Milan, 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)
Study contacts
- Principal investigator: Francesco Bandera, MD, PhD — university cardiology department, IRCCS Policlinico San Donato
- Study coordinator: Francesco Bandera, MD, PhD
- Email: Francesco.Bandera@grupposandonato.it
- Phone: (+39) 025277
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.