Heart FailureEPI-GERASNCT06582992
DNA Methylation Trajectories in Aging
An observational study of Heart Failure and Aging, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Aging
- What is being tested?
- RRBS
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2024to Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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%)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
University of Campania Luigi Vanvitelli
Naples, No States Available, 80138
Giuditta Benincasa, PhD, 3245511161
Giuditta Benincasa, PhD, 3245511161, giuditta.benincasa@unicampania.it
About this study
Official title: EPIGENETIC-SENSITIVE BIOMARKERS OF INFLAMMAGING FROM HEALTHY TO HEART FAILURE DISEASE
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
- Being tested
- RRBS
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRBSOther
Also called O-Link Targeted Proteomics
Measure of genomic regions with differentially methylated profiles and differentially expressed protein
| Study group | Role | What they receive |
|---|---|---|
| Young healthy subjects | This cohort is characterized by 50 healthy subjects aged < 40 years (blood donor volonteers) Receives: 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 Receives: 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 Receives: Other: RRBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study startNov 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuditta Benincasa, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582992
- Sponsor's protocol ID
- Aging Well in an Aging Society
- Acronym
- EPI-GERAS
- Status last verified
- Aug 2024
- First submitted
- 31 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not required
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPIGENETIC-SENSITIVE BIOMARKERS OF INFLAMMAGING FROM HEALTHY TO HEART FAILURE DISEASE
- ClinicalTrials.gov ID
- NCT06582992
- Acronym / sponsor ID
- EPI-GERAS / Aging Well in an Aging Society
- Conditions
- Heart Failure, Aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Young healthy subjects | – | Other: RRBSThis cohort is characterized by 50 healthy subjects aged < 40 years (blood donor volonteers) |
| Aged healthy subjects | – | Other: RRBSThis 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 | – | Other: RRBSThis cohort is characterized by 50 subjects aged > 60-65 years with signs and symptoms of heart failure with preserved ejection fraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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%)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RRBSAlso: O-Link Targeted ProteomicsMeasure of genomic regions with differentially methylated profiles and differentially expressed protein | Other | Aged healthy subjects, Patients with heart failure, Young healthy subjects |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No. Not required
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Aging, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuditta Benincasa, PhD (3245511161, giuditta.benincasa@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of differentially methylated positions and regions as assessed by RRBS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.