DNA Methylation Trajectories in Aging (EPI-GERAS)

EPIGENETIC-SENSITIVE BIOMARKERS OF INFLAMMAGING FROM HEALTHY TO HEART FAILURE DISEASE

The goal of this observational study is to profile changes in DNA methylation of circulating CD4+ T and CD8+ T cells from healthy young to aged with diagnosis of HFpEF, a particular phenotype of HF which is highly prevalent in aging.

The main question it aims to answer is:

-Do DNA methylation biomarkers help us to understand the role of inflammation in HFpEF during aging?

Our goal is to provide a simple large-scale panel of epigenetic-sensitive biomarkers useful in aged patients with HF in the early natural history of the disease (HFpEF).

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Aging
• Intervention / Treatment: Other: RRBS

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Giuditta Benincasa, PhD; Phone Number: 3245511161; Email: giuditta.benincasa@unicampania.it

Study Locations

• Italy
  • No States Available
    • Naples, No States Available, Italy, 80138
      • University of Campania Luigi Vanvitelli
      • Contact: Giuditta Benincasa, PhD; Phone Number: 3245511161; Email: giuditta.benincasa@unicampania.it
      • Contact: Giuditta Benincasa, PhD; Phone Number: 3245511161

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A total of 150 subjects will be enrolled; n=50 healthy young, n=50 aged (≥65) without signs and symptoms of heart failure, and n=50 aged (≥65) with diagnosis of HFpEF will be enrolled at Trasfusion Medicine and Cardiology Departments of University of Campania Luigi Vanvitelli; Each group will be matched for sex (25 M and 25 F), smoker habits, and comorbidities. Demographic and clinical characteristics will be collected both from patients and healthy subjects at baseline. For HFpEF patients, echocardiographic parameters will be reported based on the echocardiogram acquired at the time of enrollment.

Description

Inclusion Criteria:

• Healthy subjects aged between 18 and 40 years
• Aged subjects (≥65) without signs and symptoms of heart failure
• Aged subjects (≥65) with diagnosis of heart failure with preserved ejection fraction (EF major than 50%)

Exclusion Criteria:

• Heart failure with reduced ejection fraction (EF minor than 40%)
• Heart failure with mildly reduced EF (HFmrEF) (EF 41-49%)
• History or diagnosis of cancer and inflammatory diseases

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Young healthy subjects; This cohort is characterized by 50 healthy subjects aged < 40 years (blood donor volonteers)	Other: RRBS; Measure of genomic regions with differentially methylated profiles and differentially expressed protein; Other Names: O-Link Targeted Proteomics
Aged healthy subjects; This cohort is characterized by 50 healthy subjects aged > 60-65 years (blood donor volonteers) without signs and symptoms of heart failure	Other: RRBS; Measure of genomic regions with differentially methylated profiles and differentially expressed protein; Other Names: O-Link Targeted Proteomics
Patients with heart failure; This cohort is characterized by 50 subjects aged > 60-65 years with signs and symptoms of heart failure with preserved ejection fraction	Other: RRBS; Measure of genomic regions with differentially methylated profiles and differentially expressed protein; Other Names: O-Link Targeted Proteomics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of differentially methylated positions and regions as assessed by RRBS	We will identify a panel of positions and regions of the genome which are differentially methylated using as measure diff.meth more than or minor than 2 and p minor than 0.05	6 months

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: August 31, 2024
• First Submitted That Met QC Criteria: August 31, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 31, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Aging Well in an Aging Society

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not required

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No