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NCT Number: NCT06616038

Heart Failure Biomarkers

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).

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Hart Failure Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Data Collection

Other

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

Primary outcomes

  1. 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

  1. FAR (=Fibrinogen/Albumin) and functional ultrasound

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Direzione Scientifica Direzione Scientifica

CONTACT

[email protected]

0283502227 ext. 0039

Fabrizio Dr. Colombo

CONTACT

[email protected]

0283502227 ext. 0039

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: BIOHF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 27, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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