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Not yet recruiting NCT06616038

Heart Failure Biomarkers

— Observational Atrial Fibrillation (AF) Hart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data collection.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF), Hart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Data collection
    Given the observational nature of the study, the intervention is a simple data collection

Primary outcome measures

  • Evaluation of FAR [Time frame: At Hospital admission]
Secondary outcome measures (1)
  • FAR (=Fibrinogen/Albumin) and functional ultrasound [Time frame: At Hospital admission and at hospital discharge (assessed up to 1 months)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 2 centers
  • IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan
  • IRCCS Galeazzi-Sant'Ambrogio — Milan

Identifiers

NCT: NCT06616038 · BIOHF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗