Heart Failure Biomarkers

NCT06616038 | Not Yet Recruiting

• 1 other identifier: BIOHF
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 2

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).

Conditions

Atrial Fibrillation (AF); Hart Failure

Keywords

Hart failure; Ejection fraction; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Evaluation of FAR

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

  At Hospital admission

Secondary Outcomes (1)

• FAR (=Fibrinogen/Albumin) and functional ultrasound

  At Hospital admission and at hospital discharge (assessed up to 1 months)

Study Arms (2)

heart failure patients (HFrEF and HFpEF) without atrial fibrillation

Will be enrolled 57 patients with heart failure patients (HFrEF and HFpEF) without atrial fibrillation

Other: Data collection

heart failure patients (HFrEF and HFpEF) with atrial fibrillation

Will be enrolled 57 patients with heart failure patients (HFrEF and HFpEF) with atrial fibrillation

Other: Data collection

Interventions

Data collection OTHER

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

heart failure patients (HFrEF and HFpEF) with atrial fibrillation; heart failure patients (HFrEF and HFpEF) without atrial fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Will be enrolled 114 patients admitted to the Hospital for heart failure of first diagnosis or already undergoing therapy. In particular, 57 patients with heart failure and 57 patients with heart failure and fibrillation will be included.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (2)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy, 20157, Italy

Location

IRCCS Galeazzi-Sant'Ambrogio

Milan, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Fabrizio Dr. Colombo

CONTACT

0283502227; direzionescientifica.ogsa@grupposandonato.it

Direzione Scientifica Direzione Scientifica

CONTACT

0283502227; direzionescientifica.ogsa@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 27, 2024
• Study Start: October 30, 2024
• Primary Completion: August 30, 2025
• Study Completion: October 30, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

IT (2)