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Clinical Trials/NCT06616038
NCT06616038
Not yet recruiting
Not Applicable

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

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio2 sites in 1 country114 target enrollmentOctober 30, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation (AF)
Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Enrollment
114
Locations
2
Primary Endpoint
Evaluation of FAR
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 30, 2024
End Date
October 30, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Evaluation of FAR

Time Frame: At Hospital admission

Evaluate FAR (=Fibrin/Albumin) in heart failure HFrEF and HFpEF with or without atrial fibrillation.

Secondary Outcomes

  • FAR (=Fibrinogen/Albumin) and functional ultrasound(At Hospital admission and at hospital discharge (assessed up to 1 months))

Study Sites (2)

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