Atrial Fibrillation (AF)BIOHFNCT06616038
Heart Failure Biomarkers
An observational study of Atrial Fibrillation (AF) and Hart Failure, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Hart Failure
- What is being tested?
- Data collection
- How many people
- 114 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Oct 2024to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Direzione Scientifica Direzione Scientifica contact
Italy2 sites
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Italy, 20157
Direzione Scientifica Direzione Scientifica, +390283502227, direzionescientifica.ogsa@grupposandonato.it
IRCCS Galeazzi-Sant&#39;Ambrogio
Milan
Direzione Scientifica Direzione Scientifica, +390283502227, direzionescientifica.ogsa@grupposandonato.it
Fabrizio Dr. Colombo
About this study
Official title: 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).
Read the 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.
- Conditions
- Atrial Fibrillation (AF), Hart Failure
- Being tested
- Data collection
- Keywords
- Hart failure, Ejection fraction, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Given the observational nature of the study, the intervention is a simple data collection
| Study group | Role | What they receive |
|---|---|---|
| heart failure patients (HFrEF and HFpEF) without atrial fibrillation | Will be enrolled 57 patients with heart failure patients (HFrEF and HFpEF) without atrial fibrillation Receives: 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 Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of FAR
Evaluate FAR (=Fibrin/Albumin) in heart failure HFrEF and HFpEF with or without atrial fibrillation.
Measured: At Hospital admission
Secondary outcomes (1)
FAR (=Fibrinogen/Albumin) and functional ultrasound
Correlate FAR to functional ultrasound indices of atrium and ventricle and to the presence of atrial fibrillation.
Measured: At Hospital admission and at hospital discharge (assessed up to 1 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616038
- Sponsor's protocol ID
- BIOHF
- Acronym
- BIOHF
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Assessment in Heart Failure with Reduced Systolic Function (HFrEF) and Preserved Systolic Function (HFpEF)
- ClinicalTrials.gov ID
- NCT06616038
- Acronym / sponsor ID
- BIOHF / BIOHF
- Conditions
- Atrial Fibrillation (AF), Hart Failure
- Keywords
- Hart failure, Ejection fraction, atrial fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heart failure patients (HFrEF and HFpEF) without atrial fibrillation | – | Other: Data collectionWill be enrolled 57 patients with heart failure patients (HFrEF and HFpEF) without atrial fibrillation |
| heart failure patients (HFrEF and HFpEF) with atrial fibrillation | – | Other: Data collectionWill be enrolled 57 patients with heart failure patients (HFrEF and HFpEF) with atrial fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionGiven the observational nature of the study, the intervention is a simple data collection | Other | heart failure patients (HFrEF and HFpEF) with atrial fibrillation, heart failure patients (HFrEF and HFpEF) without atrial fibrillation |
Primary outcome
Evaluation of FAR
Time frame: At Hospital admission
Evaluate FAR (=Fibrin/Albumin) in heart failure HFrEF and HFpEF with or without atrial fibrillation.
1 secondary outcome
FAR (=Fibrinogen/Albumin) and functional ultrasound
Time frame: At Hospital admission and at hospital discharge (assessed up to 1 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Direzione Scientifica Direzione Scientifica contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Hart Failure, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabrizio Dr. Colombo (0283502227 ext. 0039, direzionescientifica.ogsa@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of FAR (time frame: At Hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.