DNA Methylation Trajectories in Aging

Not yet recruiting

• Conditions: Aging; Heart Failure
• Interventions: Other: RRBS

• Registration Number: NCT06582992
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-31
• Study First Submitted QC: 2024-08-31
• Last Update Submitted: 2024-08-31
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Study Start: 2024-11
• Primary Completion: 2025-06
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of differentially methylated positions and regions as assessed by RRBS	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

Trial Locations

Locations (1)

University of Campania Luigi Vanvitelli; 🇮🇹 Naples, No States Available, Italy