Heart FailurerEPORtNCT05753553
Incidence and Echocardiographic Predictors of HFpEF in High-Risk Population Afferent to Italian Echo-labs Network
An observational study of Heart Failure and Heart Failure With Preserved Ejection Fraction, run by IRCCS Policlinico S. Donato at 6 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Heart Failure With Preserved Ejection Fraction
- How many people
- 1,000 participants
- Where
- 6 sitesItaly
- Study dates
- 2 Mar 2021to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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
Who cannot join
- 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%
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites, 6 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria di Bari
Bari
Andrea Guaricci, andrea.guaricci@gmail.com
Cinzia Forleo, cinzia.forleo@uniba.it
- Recruiting
IRCCS Policlinico San Donato
Milan, 20097
Francesco Bandera, Md, PhD, Francesco.Bandera@grupposandonato.it
Francesco Bandera, MD, PHd
- Recruiting
Azienda Ospedaliero-Universitaria di Modena
Modena
Alessandro Malagoli, ale.malagoli@gmail.com
- Recruiting
AUSL Romagna
Ravenna
Matteo Lisi, matteo.lisi@hotmail.it
Filippo Flamigni, filippo.flamigni@gmail.com
- Recruiting
Università degli Studi di Siena
Siena
Matteo Cameli, matteo.cameli@unisi.it
- Recruiting
Università degli studi di Verona
Verona
Enrico Tadiello, enrico.tadiello@live.it
Giovanni Benfari, giovanni.benfari@gmail.com
About this study
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.
Read more
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
- Keywords
- Echocardiographic Predictors, Heart Failure with Preserved Ejection Fraction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
incidence of HFpEF
to define the incidence of HFpEF in a high-risk cohort of patients afferent to Italian echo-lab network
Measured: after 12 months from baseline
Secondary outcomes (2)
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.
Measured: baseline
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.
Measured: after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start2 Mar 2021
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Bandera, IRCCS Policlinico S. Donato
- Investigators
- Francesco Bandera, MD, PhD, Principal investigator, university cardiology department, IRCCS Policlinico San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753553
- Sponsor's protocol ID
- 108/int/2019
- Acronym
- rEPORt
- Status last verified
- Mar 2023
- First submitted
- 17 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28492288Gerber 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.
PubMed 25895156
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Echocardiographic Predictors of HFpEF in High-Risk Population Afferent to Italian Echo-labs Network
- ClinicalTrials.gov ID
- NCT05753553
- Acronym / sponsor ID
- rEPORt / 108/int/2019
- Keywords
- Echocardiographic Predictors, Heart Failure with Preserved Ejection Fraction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
predictors of HFpEF
Time frame: baseline
predictors of HFpEF
Time frame: after 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Background: PubMed 28492288Dunlay 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.
- Background: PubMed 25895156Gerber 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Bandera, MD, PhD principal investigator
university cardiology department, IRCCS Policlinico San Donato
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Failure With Preserved Ejection Fraction, run by IRCCS Policlinico S. Donato at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Bandera, MD, PhD ((+39) 025277 ext. 4690, Francesco.Bandera@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of HFpEF (time frame: after 12 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05753553, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.