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Heart Failure With Preserved Ejection Fraction (HFPEF)The EPIC-HFpEFNCT07642921

HFpEF Phenotyping With Echo, Clinical, and Biomarkers

An observational study of Heart Failure With Preserved Ejection Fraction (HFPEF), run by University Of Perugia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
500 participants
Where
No sites listed yet
Study dates
2 Jun 2026to 31 Jul 2029
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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.

Who may be able to join

  • 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

Who cannot join

  • 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),
  • Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischemia or newly developed ischemic ECG changes), coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 3 months;
  • Chronic pulmonary disease requiring home oxygen, oral steroid therapy or hospitalization for exacerbation within 12 months;
Show all 12Show fewer
  • Congenital heart disease.
  • Primary pulmonary hypertension
  • Moderate-to-severe degenerative (primary) valve disease
  • Cardiomyopathy based on muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), or known pericardial constriction;
  • Implantation of cardioverter defibrillator (ICD) within 3 months
  • Implanted cardiac resynchronization therapy (CRT) and/or stable RV pacing.

About this study

Official title: Phenotyping Heart Failure With Preserved Ejection Fraction (HFpEF) Using Echocardiographic, Clinical, and Biomarker Parameters

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.

Read the detailed description

Study Design: A multicenter, national, non-randomized observational study with both retrospective and prospective components, conducted at approximately 10 Italian tertiary centers specializing in the management of heart failure.The registry consecutively will enroll adult patients diagnosed with HFpEF, including both inpatients and outpatients, and includes follow-up for up to 24 months or until death or withdrawal of consent. No intervention aimed at modifying standard clinical practice is planned.

Study Purpose and Rationale: The rationale for the EPIC-HFpEF registry is to:

  • describe the true prevalence of the different HFpEF phenotypes in clinical practice;
  • characterize these phenotypes using an integrated approach that includes advanced echocardiography, clinical data, and biomarkers;
  • provide the foundation for personalized medicine, tailored to the individual patient's pathophysiological profile.

Study Objectives:

Primary Objectives

  • To identify distinct phenotypes of HFpEF based on clinical parameters, echocardiographic findings (standard and advanced), biomarkers, and comorbidities.
  • To describe the prevalence and temporal evolution of the different HFpEF phenotypes in a real-world setting.

Secondary objectives

  • Evaluate the implementation of guideline-recommended therapies (neurohormonal modulators, SGLT2 inhibitors, GLP-1 agonists) and the treatment of comorbidities across the different phenotypes.
  • Analyze the associations between circulating biomarkers and structural and functional cardiac alterations.
  • Study the impact of disease duration on clinical outcomes in relation to phenotype.
  • Assess the cumulative risk of cardiovascular events and their prognostic value in the different subgroups of HFpEF.

Inclusion Criteria

  • Age ≥ 18 years.
  • Written informed consent.
  • Diagnosis of chronic or acute heart failure with:o Left ventricular ejection fraction ≥ 50%;o Elevated natriuretic peptide levels (NT-proBNP ≥300 pg/mL in sinus rhythm or ≥600 pg/mL in atrial fibrillation); or Echocardiographic evidence of increased left ventricular filling pressures.
  • NYHA Class II-IV.

The following are also included as comparison groups:

  • Patients with recovered/improved EF (previous EF <40%);
  • Patients with mildly reduced EF (40-49%, HFmrEF).

Exclusion criteria

  • Concurrent participation in interventional clinical trials.
  • Life expectancy < 1 year due to non-cardiac causes.
  • Recent infectious, inflammatory, autoimmune, or neoplastic diseases (≤6 months).
  • Advanced chronic kidney disease (eGFR <15 ml/min/1.73 m²).
  • Recent major cardiovascular events (MI, stroke, cardiac surgery within the last 3 months).
  • Severe pulmonary diseases, congenital heart disease, primary pulmonary hypertension.
  • Moderate-to-severe degenerative valvular disease, specific or constrictive cardiomyopathies.
  • Recent implantation of an ICD or cardiac resynchronization therapy.

Study Duration

  • Enrollment period: 12 months.
  • Follow-up for each patient: up to 24 months.
  • Total study duration: approximately 3 years.

Scheduled visits include:

  • baseline (T1),
  • 6-month follow-up (T2),
  • 12-month follow-up (T3),
  • additional clinical follow-up for up to 24 months to collect event data.

Sample Size We plan to enroll approximately 500 patients with HFpEF, assuming an average of 50 patients per participating center.This sample size is considered adequate for identifying phenotypic clusters and estimating their prevalence in the real-world population of patients with HFpEF.ConclusionThe EPIC-HFpEF registry aims to improve understanding of the clinical and pathophysiological complexity of HFpEF by identifying phenotypes that are prognostically relevant and potentially responsive to targeted therapeutic strategies, with direct implications for clinical practice and the design of future interventional studies.

Keywords
Phenotyping, Heart Failure, Ejection Fraction, Obesity, Diabetes, Chronic Kidney Disease, HFpEF
Medical subject headings
Heart Failure, Obesity, Diabetes Mellitus, Renal Insufficiency, Chronic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At Baseline

Secondary outcomes (3)
  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

    Measured: 1 year, year 1

  2. 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

    Measured: At baseline

  3. 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

    Measured: 3 years, year 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2026
  2. Study start2 Jun 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

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
Other
Enrolment
500 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07642921
Sponsor's protocol ID
CET N° 5131/26
Acronym
The EPIC-HFpEF
Status last verified
Jun 2026
First submitted
23 Mar 2026
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Patel HC, Hayward C, Dungu JN, Papadopoulou S, Saidmeerasah A, Ray R, Di Mario C, Shanmugam N, Cowie MR, Anderson LJ. Assessing the Eligibility Criteria in Phase III Randomized Controlled Trials of Drug Therapy in Heart Failure With Preserved Ejection Fraction: The Critical Play-Off Between a "Pure" Patient Phenotype and the Generalizability of Trial Findings. J Card Fail. 2017 Jul;23(7):517-524. doi: 10.1016/j.cardfail.2017.04.006. Epub 2017 Apr 18.

    PubMed 28434933
  • Redfield MM, Borlaug BA. Heart Failure With Preserved Ejection Fraction: A Review. JAMA. 2023 Mar 14;329(10):827-838. doi: 10.1001/jama.2023.2020.

    PubMed 36917048
  • Kittleson MM, Panjrath GS, Amancherla K, Davis LL, Deswal A, Dixon DL, Januzzi JL Jr, Yancy CW. 2023 ACC Expert Consensus Decision Pathway on Management of Heart Failure With Preserved Ejection Fraction: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2023 May 9;81(18):1835-1878. doi: 10.1016/j.jacc.2023.03.393. Epub 2023 Apr 19. No abstract available.

    PubMed 37137593
  • Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

    PubMed 35363499
  • McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Skibelund AK; ESC Scientific Document Group. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023 Oct 1;44(37):3627-3639. doi: 10.1093/eurheartj/ehad195. No abstract available.

    PubMed 37622666

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure With Preserved Ejection Fraction (HFPEF), run by University Of Perugia.

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 4 inclusion and 12 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: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of HFpEF phenotypes (time frame: At 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 NCT07642921, which also lists 5 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 11 Jun 2026.

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