DNA Methylation Trajectories in Aging
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Campania Luigi Vanvitelli
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%)
Disqualifiers
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 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
RRBS
Other interventionMeasure of genomic regions with differentially methylated profiles and differentially expressed protein
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Young healthy subjects1 intervention
Group B: Aged healthy subjects1 intervention
Group C: Patients with heart failure1 intervention
Trial outcomes
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
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: