Inflammation, Epigenetics in CHF Patients With AF

NCT07152301 | Completed

• 1 other identifier: UPalermo8
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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.
• 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.

Conditions

Congestive Heart Failure Chronic; Atrial Fibrillation (Permanent)

Keywords

atrial fibrillation; congestive hearth failure; cytokine; miRNA

Outcome Measures

Primary Outcomes (1)

• 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 %

  From January 2020 to May 2022

Secondary Outcomes (2)

• epigenetic alterations and cardiac remodelling

  From January 2020 to May 2022

• inflammation and epigenetic alterations

  From January 2020 to May 2022

Study Arms (2)

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

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

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

You may qualify if:

• ≥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

You may not qualify if:

• \- 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
• 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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Internal Medicine and Stroke Care Ward, Policlinic Hospital of Palermo, Sicily

Palermo, PA, 90127, Italy

Location

Related Publications (3)

• 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.

  PMID: 28100627 BACKGROUND

• Harada 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.

  PMID: 25746525 BACKGROUND

• Carr 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.

  PMID: 23598154 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma sample for evaluation of blood levels of cytokines and miRNA

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: September 3, 2025
• Study Start: January 1, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: August 2025-August 2030
• Access Criteria: Professor Tuttolomondo will be responsible for responding to any queries regarding the protocol or results from those who request clarification via his institutional email address.

Locations

IT (1)