Heart Failure Biomarkers

Not yet recruiting

• Conditions: Atrial Fibrillation (AF); Hart Failure

• Registration Number: NCT06616038
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-24
• Last Update Submitted: 2024-09-24
• Study First Posted: 2024-09-27
• Last Update Posted: 2024-09-27
• Study Start: 2024-10-30
• Primary Completion: 2025-08-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 114

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of FAR	At Hospital admission	Evaluate FAR (=Fibrin/Albumin) in heart failure HFrEF and HFpEF with or without atrial fibrillation.

Secondary Outcome Measures

Name	Time	Method
FAR (=Fibrinogen/Albumin) and functional ultrasound	At Hospital admission and at hospital discharge (assessed up to 1 months)	Correlate FAR to functional ultrasound indices of atrium and ventricle and to the presence of atrial fibrillation.

Trial Locations

Locations (2)

IRCCS Galeazzi-Sant'Ambrogio; 🇮🇹 Milano, Italy

IRCCS Ospedale Galeazzi-Sant'Ambrogio; 🇮🇹 Milan, Italy