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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05475028
Other study ID # UniCampania
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 14, 2021
Est. completion date June 14, 2022

Study information

Verified date July 2022
Source University of Campania "Luigi Vanvitelli"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Heart failure (HF) is a syndrome, resulting from structural or functional impairment of ventricular filling or ejection of blood. Effective HF management depends on accurate and rapid diagnosis requiring assessment of symptoms and physical signs in combination with advanced and expensive imaging tools. However, several challenges arise from the traditional symptom-based diagnosis because co-morbidities of HF have similar presentations. This implies the need for a deeper knowledge of mechanistic links among genetic and epigenetic events governing the pathophysiology of HF leading to a novel molecular-based system to differentiate HF phenotypes. Now, it is emerging that the pathophysiology of HFpEF and HFrEF is different, it provides an opportunity to identify biomarker candidates that could aid in HF diagnosis and stratification between these two forms of the disease. The aim of PRESMET project is to perform liquid biopsy strategies to identify novel putative non-invasive epigenetic-sensitive biomarkers that could be used either alone or in combination with established diagnostic tests, such as natriuretic peptide, to help differentiate HFpEF from HFrEF. The Investigators will perform DNA methylation analysis on CD4+ T cells isolated from patients versus controls. Remarkably, big data generated from NGS tools will be analyzed by advanced network-oriented algorithms. Our results may provide a useful clinical roadmap in order to improve precision medicine and personalized therapy of HF.


Description:

The Investigators will perform the first Network Medicine approach to integrate the DNA methylome of circulating CD4+T cells and clinical parameters in patients with HFpEF and HFrEF. Liquid biopsy strategies will be performed to isolate PBMCs and purificate CD4+ T cells. Successivelly, genomic DNA will be extracted on columns and will be send out for RRBS. Network-oriented algorithms will be used to analyze DNA methylation signatures and to identify specific epigenetic changes in relation to left ventricle ejection fraction. Network-oriented DNA methylation signatures will be integrated to the H2FPEF point-of-care calculator and, then, will be validated by the use of q-RT-PCR, WB, and ELISA.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 14, 2022
Est. primary completion date January 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - HFrEF (LVEF < 40%) - HFpEF (LVEF > 50%) Exclusion Criteria: - Patients with HF with a history of a reduced LVEF = 40% (HFrEF) who recover LV function (LVEF = 50%) - Chronic inflammatory diseases - Cancer

Study Design


Intervention

Other:
RRBS
Reduced Representation Bisulfite Sequencing

Locations

Country Name City State
Italy University of Campania Luigi Vanvitelli Naples

Sponsors (4)

Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli" Federico II University, Monaldi Hospital, University of Alabama at Birmingham

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Napoli C, Benincasa G, Donatelli F, Ambrosio G. Precision medicine in distinct heart failure phenotypes: Focus on clinical epigenetics. Am Heart J. 2020 Jun;224:113-128. doi: 10.1016/j.ahj.2020.03.007. Epub 2020 Mar 12. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of differentially methylated regions (DMRs) in CD4+ T cells The Investigators will identify the panel of DMRs able to distinguish HFpEF vs. HFrEF, HFpEF vs. healthy controls, and HFrEF vs. healthy controls. 3 months
Primary Levels of differentially expressed genes in CD4+ T cells The Investigators will measure the levels of gene expression of selected genes (qRT-PCR) in HFpEF vs. HFrEF, HFpEF vs. healthy controls, and HFrEF vs. healthy controls. 1 month
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