Heart Failure Biomarkers (BIOHF)

September 24, 2024 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Other: Data collection
Given the observational nature of the study, the intervention is a simple data collection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At Hospital admission and at hospital discharge (assessed up to 1 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2024

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOHF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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