Heart Failure Biomarkers

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06616038

Acronym

BIOHF

Enrollment

114

Registered

2024-09-27

Start date

2024-10-30

Completion date

2025-10-30

Last updated

2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF), Hart Failure

Keywords

Hart failure, Ejection fraction, atrial fibrillation

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.

Interventions

OTHERData collection

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactFabrizio Dr. Colombo

direzionescientifica.ogsa@grupposandonato.it0283502227

Backup ContactDirezione Scientifica Direzione Scientifica