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Completed

NCT Number: NCT07152301

Inflammation, Epigenetics in CHF Patients With AF

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.

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Key information

Conditions

Congestive Heart Failure Chronic Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation (Permanent) Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Palermo, PA, 90127, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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 %

Secondary outcomes

  1. epigenetic alterations and 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 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 %

  2. inflammation and epigenetic alterations

    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 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)

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 3, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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