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NCT Number: NCT06582992

DNA Methylation Trajectories in Aging

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).

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Key information

Conditions

Heart Failure Aging Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Campania Luigi Vanvitelli

Naples, No States Available, 80138, Italy

Location contact

Giuditta Benincasa, PhD

CONTACT

3245511161

Giuditta Benincasa, PhD

CONTACT

[email protected]

3245511161

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

RRBS

Other

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

Other names: O-Link Targeted Proteomics

Primary outcomes

Number of differentially methylated positions and regions as assessed by RRBS

Time frame: 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Giuditta Benincasa, PhD

CONTACT

[email protected]

3245511161

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Acronym: EPI-GERAS

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 3, 2024
Registry last updated: Sep 3, 2024

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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