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ClinicalTrials.gov ID

NCT06616038

Lead Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

114Estimated

Last Update Posted

Sep 27, 2024Actual

Start Date

Oct 30, 2024Estimated

Primary Completion Date

Aug 30, 2025Estimated

Completion Date

Oct 30, 2025Estimated

Official Title

Biomarker Assessment in Heart Failure with Reduced Systolic Function (HFrEF) and Preserved Systolic Function (HFpEF)

Brief Summary

Systemic inflammation is closely associated with the development and progression of heart failure (HF). The study assessed the fibrin/albumin (FAR) ratio, a very important biomarker, as a prognostic indicator of HE. Study population is composed by patients who were addicted with heart failure diagnosed for the first time or already under treatment (NYHA class II-IV) and reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).

Detailed Description

Prospective, observational, single-center study, which involves the enrollment of patients affected by heart failure of first diagnosis or already in therapy, who will be subjected to an analysis of the Albumin/fibrinogen ratio. Subjects will not be subjected to specific visits or services for the study: clinical and anamnestic data will be collected during routine visits.

• Atrial Fibrillation (AF)
• Hart Failure

• Data collection

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Patients ≥ 18 years
• Patients with newly diagnosed or already treated heart failure (NYHA class II-IV) with HFrEF and HFpEF with and without atrial fibrillation.
• Patients who sign the consent to participate in the study

Exclusion Criteria:

• Patients with infectious/autoimmune diseases, neoplasms, liver failure, renal failure (Cl creatinine < 30 mL/L), structural cardiomyopathies and pericarditis.
• Pregnant/breastfeeding women (verified by self-declaration)

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioOTHER

direzionescientifica.ogsa@grupposandonato.it+390283502227