DNA Methylation Trajectories in Aging

NCT06582992 | Not Yet Recruiting DMC

• 1 other identifier: Aging Well in an Aging Society
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Heart Failure; Aging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Young healthy subjects

This cohort is characterized by 50 healthy subjects aged \< 40 years (blood donor volonteers)

Other: RRBS

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

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

Interventions

RRBS OTHER

Measure of genomic regions with differentially methylated profiles and differentially expressed protein

Also known as: O-Link Targeted Proteomics

Aged healthy subjects; Patients with heart failure; Young healthy subjects

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

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.

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania Luigi Vanvitelli

Naples, No States Available, 80138, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Isolation of circulating T lymphocytes and DNA extraction; isolation of plasma and protein detection

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Giuditta Benincasa, PhD

CONTACT

3245511161; giuditta.benincasa@unicampania.it

Study Design

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

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: September 3, 2024
• Study Start: November 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)