HFpEF Phenotyping With Echo, Clinical, and Biomarkers
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Of Perugia
About this trial
The EPIC-HFpEF registry is a nationwide Italian study that follows people with a specific type of heart failure called HFpEF. About 500 patients will be enrolled from several specialized hospitals and monitored for up to two years, without changing their usual treatment.
The goal is to better understand this complex condition by identifying different patient "types" based on clinical features, heart imaging, and blood markers. Researchers will also look at how these groups are treated in real life and how their disease progresses over time.
By doing this, the study aims to improve how doctors classify and manage HFpEF, moving toward more personalized and effective care for patients in the future.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years old
Signed patient informed consent form (ICF)
Diagnosis of chronic (documented HF hospitalization in the last year) or acute decompensated HF shown by signs and symptoms of HF and LVEF >50% and, according to guidelines and the universal definition of HF, elevated levels of natriuretic peptides (NT-proBNP ≥300 pg/ml in sinus rhythm or NTproBNP ≥600 pg/ml in atrial fibrillation), at the time of enrolment (10)
Echocardiographic evidence of increased estimated LV filling pressures according to current guidelines
Disqualifiers
Planned participation or participation in a clinical trial;
Life expectancy < 1 year because of non-cardiac causes;
History of recent (6 months) infective, or inflammatory, autoimmune or neoplastic diseases.
Stage >4 CKD (estimated glomerular filtration rate [eGFR] < 15 ml/min/1.73m2),
Trial population
The study population will consist of consecutive patients with HF (NYHA class II - IV), aged 18 years or older, able to give their written informed consent to participate to the registry. Each patient will be uniquely identified in the study by a combination of his/her site number and patient number. No name will be entered in the database. Once obtained approval from each Ethics Committee center, consecutive patients will be included, up to the achievement of the study size. Patients may also be enrolled retrospectively, provided they give their written informed consent during a follow-up visit. Enrollment will be performed during outpatient visits or at-discharge in patients hospitalized for HF. Outpatient's visits will be further classified as planned or unplanned visits for worsening HF symptoms. Patient data collected during the study will include demographics, medical history, vital signs, LVEF and main cardiac structure and function parameters, and laboratory assessments.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Prevalence of HFpEF phenotypes
to evaluate the prevalence of distinct phenotypic subgroups of HFpEF agnostically classified (unsupervised) using detailed standard and advanced echocardiography (at rest and/or during exercise), clinical evaluation, biomarker characteristics, and comorbidities assessment
Time frame
At BaselineSecondary outcomes
1
Prevalence of treatment patterns according to different phenotypes
Implementation of Guidelines-indicated drugs, including neurohormonal modulators, SGLT2-inhibitors, GLP1 agonists, and comorbidities-related treatment (including atrial fibrillation, iron deficiency, kidney dysfunction), according to the different phenotypes
Time frame
1 year, year 12
Correlations between biomarkers and structural and functional alterations of the heart
Assessing biomarker correlations with specific morphological and structural alterations of the heart, according to the different phenotypes
Time frame
At baseline3
Rate of major cardiovascular events
To assess cumulative rate of CV events (- death from cardiovascular cause; * all-cause death; * Heart Failure re-hospitalization; * the composite of death from cardiovascular cause and HF-rehospitalization; * Incident Atrial Fibrillation; * Non-fatal Myocardial infarction; * Non-fatal stroke; * Hospitalization for acute kidney injury or other kidney disease event including dialysis or end-stage renal disease defined as eGFR \< 15 mL/min/1.73 m2 or the need for renal replacement therapy) according to different HFpEF phenotypes
Time frame
3 years, year 3Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Of Perugia
Lead sponsor
Azienda Ospedaliera di Perugia
Collaborator
Ospedale Le Scotte
Collaborator
University of Foggia
Collaborator
Source ClinicalTrials.gov
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