Congestive Heart Failure ChronicNCT07152301
Inflammation, Epigenetics in CHF Patients With AF
An observational study of Congestive Heart Failure Chronic and Atrial Fibrillation (Permanent), run by University of Palermo at 1 site in Italy.
Trial summary
the goal of this case-control cross-sectional study is assessing in a cohort of patients with CHF and permanent AF The serum levels of some candidate cytokine variables and their relationship with some selected metabolic variables and some echocardiographic variables. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure Chronic, Atrial Fibrillation (Permanent)
- How many people
- 164 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 31 May 2022
- 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: consecutive patients with chronic heart failure (CHF) and permanent non-valvular atrial fibrillation (AF), and consecutive patients with CHF, the same risk factors, but sinus rhythm and no prior AF history, admitted to the Internal Medicine and Stroke Care Ward of the "P. Giaccone" Hospital, Palermo
Who may be able to join
- ≥18 years
- Left ventricular ejection fraction >40%
- New York Heart Association class II-IV symptoms
- NT-proBNP ≥600 pg/mL, or ≥900 pg/mL if AF was present on baseline electrocardiography
Who cannot join
- Other AF subtypes (paroxysmal, persistent, long-standing persistent)
- At least one of the following criteria:
- Acute heart failure
- NYHA IV
- NT-proBNP >4000 pg/mL
- Significant valvular disease
Show all 12Show fewer
- Mechanical prosthesis
- Cardiovascular implantable devices
- Active malignancy
- Inflammatory or infectious diseases
- Severe renal (eGFR <30 mL/min/m²) or hepatic failure
- Chronic steroid/anti-inflammatory therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Internal Medicine and Stroke Care Ward, Policlinic Hospital of Palermo, Sicily
Palermo, PA, 90127
About this study
Official title: Inflammatory Activation, Epigenetic Signature and Morpho-structural Alteration in a Cohort of Patients With Chronic Heart Failure and Permanent Non-valvular Atrial Fibrillation: a Cross-sectional Study
the goal of this case-control cross-sectional study is assessing in a cohort of patients with CHF and permanent AF
- The serum levels of some candidate cytokine variables and their relationship with some selected metabolic variables and some echocardiographic variables.
- the expression degree of some selected miRNA with a pathogenetic relation to atrial fibrillation and the related cardiac remodelling.
- to analyze the correlation between selected miRNA and the selected cytokines.
- Keywords
- atrial fibrillation, congestive hearth failure, cytokine, miRNA
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with CHF and atrial fibrillation (CHF + AF) | patients with chronic heart failure (CHF) and permanent non-valvular atrial fibrillation (AF) | |
| Patients with CHF and no atrial fibrillation (CHF no-AF) | patients with CHF no prior history of atrial fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammation and structural cardiac remodelling
in both arms of the study (AF + CHF and CHF no AF) a blood sample will be performed for the determination of serum values of inflammatory cytokines (CRP in mg/l; IL6 in pg/ml) and a transthoracic echocardiogram for the evaluation of the left atrial volume index in ml/m2 and the left atrial strain %
Measured: From January 2020 to May 2022
Secondary outcomes (2)
epigenetic alterations and cardiac remodelling
in both arms of the study (AF + CHF and CHF no AF) a blood sample will be performed for the determination of the expression degree of some selected miRNA with a pathogenetic relation to atrial fibrillation (hsa-miR-1-3p, hsa-miR-26a-5p, hsa-miR-21-5p in nmol/l), and a transthoracic echocardiogram for the evaluation of the left atrial volume index in ml/m2 and the left atrial strain %
Measured: From January 2020 to May 2022
inflammation and epigenetic alterations
in both arms of the study (AF + CHF and CHF no AF) a blood sample will be performed for the determination of the expression degree of some selected miRNA with a pathogenetic relation to atrial fibrillation (hsa-miR-1-3p, hsa-miR-26a-5p, hsa-miR-21-5p in nmol/l), and a blood sample for the determination of serum values of inflammatory cytokines (CRP in mg/l; IL6 in pg/ml)
Measured: From January 2020 to May 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Jan 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart Failure ChronicStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonino Tuttolomondo, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152301
- Sponsor's protocol ID
- UPalermo8
- Status last verified
- Sep 2025
- First submitted
- 16 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hage C, Michaelsson E, Linde C, Donal E, Daubert JC, Gan LM, Lund LH. Inflammatory Biomarkers Predict Heart Failure Severity and Prognosis in Patients With Heart Failure With Preserved Ejection Fraction: A Holistic Proteomic Approach. Circ Cardiovasc Genet. 2017 Feb;10(1):e001633. doi: 10.1161/CIRCGENETICS.116.001633.
PubMed 28100627Harada M, Van Wagoner DR, Nattel S. Role of inflammation in atrial fibrillation pathophysiology and management. Circ J. 2015;79(3):495-502. doi: 10.1253/circj.CJ-15-0138. Epub 2015 Feb 16.
PubMed 25746525Carr JJ, Hendel RC, White RD, Patel MR, Wolk MJ, Bettmann MA, Douglas P, Rybicki FJ, Kramer CM, Woodard PK, Shaw LJ, Yucel EK; American College of Cardiology Foundation; American College of Cardiology Foundation. 2013 appropriate utilization of cardiovascular imaging: a methodology for the development of joint criteria for the appropriate utilization of cardiovascular imaging by the American College of Cardiology Foundation and American College of Radiology. J Am Coll Radiol. 2013 Jun;10(6):456-63. doi: 10.1016/j.jacr.2013.03.019. Epub 2013 Apr 15.
PubMed 23598154
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Activation, Epigenetic Signature and Morpho-structural Alteration in a Cohort of Patients With Chronic Heart Failure and Permanent Non-valvular Atrial Fibrillation: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07152301
- Acronym / sponsor ID
- UPalermo8
- Keywords
- atrial fibrillation, congestive hearth failure, cytokine, miRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 3 Sep 2025 (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.
the goal of this case-control cross-sectional study is assessing in a cohort of patients with CHF and permanent AF
- The serum levels of some candidate cytokine variables and their relationship with some selected metabolic variables and some echocardiographic variables.
- the expression degree of some selected miRNA with a pathogenetic relation to atrial fibrillation and the related cardiac remodelling.
- to analyze the correlation between selected miRNA and the selected cytokines.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with CHF and atrial fibrillation (CHF + AF) | – | –patients with chronic heart failure (CHF) and permanent non-valvular atrial fibrillation (AF) |
| Patients with CHF and no atrial fibrillation (CHF no-AF) | – | –patients with CHF no prior history of atrial fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients with chronic heart failure (CHF) and permanent non-valvular atrial fibrillation (AF), and consecutive patients with CHF, the same risk factors, but sinus rhythm and no prior AF history, admitted to the Internal Medicine and Stroke Care Ward of the "P. Giaccone" Hospital, Palermo
Key inclusion criteria (4 listed)
- ≥18 years
- Left ventricular ejection fraction >40%
- New York Heart Association class II-IV symptoms
- NT-proBNP ≥600 pg/mL, or ≥900 pg/mL if AF was present on baseline electrocardiography
Key exclusion criteria (12 listed)
- Other AF subtypes (paroxysmal, persistent, long-standing persistent)
- Acute heart failure
- NYHA IV
- NT-proBNP >4000 pg/mL
- Significant valvular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
inflammation and structural cardiac remodelling
Time frame: From January 2020 to May 2022
in both arms of the study (AF + CHF and CHF no AF) a blood sample will be performed for the determination of serum values of inflammatory cytokines (CRP in mg/l; IL6 in pg/ml) and a transthoracic echocardiogram for the evaluation of the left atrial volume index in ml/m2 and the left atrial strain %
2 secondary outcomes
epigenetic alterations and cardiac remodelling
Time frame: From January 2020 to May 2022
inflammation and epigenetic alterations
Time frame: From January 2020 to May 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 28100627Hage C, Michaelsson E, Linde C, Donal E, Daubert JC, Gan LM, Lund LH. Inflammatory Biomarkers Predict Heart Failure Severity and Prognosis in Patients With Heart Failure With Preserved Ejection Fraction: A Holistic Proteomic Approach. Circ Cardiovasc Genet. 2017 Feb;10(1):e001633. doi: 10.1161/CIRCGENETICS.116.001633.
- Results publication: PubMed 25746525Harada M, Van Wagoner DR, Nattel S. Role of inflammation in atrial fibrillation pathophysiology and management. Circ J. 2015;79(3):495-502. doi: 10.1253/circj.CJ-15-0138. Epub 2015 Feb 16.
- Results publication: PubMed 23598154Carr JJ, Hendel RC, White RD, Patel MR, Wolk MJ, Bettmann MA, Douglas P, Rybicki FJ, Kramer CM, Woodard PK, Shaw LJ, Yucel EK; American College of Cardiology Foundation; American College of Cardiology Foundation. 2013 appropriate utilization of cardiovascular imaging: a methodology for the development of joint criteria for the appropriate utilization of cardiovascular imaging by the American College of Cardiology Foundation and American College of Radiology. J Am Coll Radiol. 2013 Jun;10(6):456-63. doi: 10.1016/j.jacr.2013.03.019. Epub 2013 Apr 15.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure Chronic and Atrial Fibrillation (Permanent), run by University of Palermo at 1 site 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammation and structural cardiac remodelling (time frame: From January 2020 to May 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07152301, which also lists 3 linked publications.
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 4 Sep 2025.