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NCT07642921
HFpEF Phenotyping With Echo, Clinical, and Biomarkers
Conditions: Heart Failure With Preserved Ejection Fraction (HFPEF)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 500
Sponsor: University Of Perugia
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.
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
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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;
* 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.
Source: ClinicalTrials.gov (NCT07642921). StuddyBuddy aggregates publicly available trial information.