Heart Failure Biomarkers

NCT ID: NCT06616038

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-30

Study Completion Date

2025-10-30

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation (AF) Hart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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heart failure patients (HFrEF and HFpEF) without atrial fibrillation

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

Data collection

Intervention Type OTHER

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

Data collection

Intervention Type OTHER

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

Interventions

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Data collection

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy, Italy

Site Status

IRCCS Galeazzi-Sant'Ambrogio

Milan, , Italy

Site Status

Countries

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Italy

Central Contacts

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Fabrizio Dr. Colombo

Role: CONTACT

0283502227 ext. 0039

Direzione Scientifica Direzione Scientifica

Role: CONTACT

0283502227 ext. 0039

Facility Contacts

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Direzione Scientifica Direzione Scientifica

Role: primary

+390283502227

Direzione Scientifica Direzione Scientifica

Role: primary

+390283502227

Fabrizio Dr. Colombo

Role: backup

Other Identifiers

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BIOHF

Identifier Type: -

Identifier Source: org_study_id

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