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DNA Methylation Trajectories in Aging (EPI-GERAS)

U

University of Campania "Luigi Vanvitelli"

Status

Not yet enrolling

Conditions

Aging
Heart Failure

Treatments

Other: RRBS

Study type

Observational

Funder types

Other

Identifiers

NCT06582992
Aging Well in an Aging Society

Details and patient eligibility

About

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).

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

150 participants in 3 patient groups

Young healthy subjects
Description:
This cohort is characterized by 50 healthy subjects aged \< 40 years (blood donor volonteers)
Treatment:
Other: RRBS
Aged healthy subjects
Description:
This cohort is characterized by 50 healthy subjects aged \> 60-65 years (blood donor volonteers) without signs and symptoms of heart failure
Treatment:
Other: RRBS
Patients with heart failure
Description:
This cohort is characterized by 50 subjects aged \> 60-65 years with signs and symptoms of heart failure with preserved ejection fraction
Treatment:
Other: RRBS

Trial contacts and locations

1

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Central trial contact

Giuditta Benincasa, PhD

Data sourced from clinicaltrials.gov

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