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NCT05475028: PRESMET
Network Medicine Approaches to Classify Heart Failure With PReserved Ejection Fraction by Signatures of DNA Methylation and Point-of-carE Risk calculaTors (PRESMET)
trial testing RRBS in Heart Failure, Diastolic in 60 participants. Completed in 14 June 2022.
14 January 2022
Quick facts
| Lead sponsor | University of Campania Luigi Vanvitelli |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 14 September 2021 |
| Primary completion | 14 January 2022 |
| Estimated completion | 14 June 2022 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- RRBS
Conditions studied
- Heart Failure, Diastolic — all drugs for Heart Failure, Diastolic →
- Heart Failure, Systolic — all drugs for Heart Failure, Systolic →
- Pulmonary Hypertension — all drugs for Pulmonary Hypertension →
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
Sponsor
University of Campania Luigi Vanvitelli
Who can join
18 and older, any sex, with Heart Failure, Diastolic or Heart Failure, Systolic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A pilot study on DNA methylation changes for non-invasive molecular diagnostics in heart failure.
Benincasa G, Cacciatore F, Pepin ME, Curcio F, et al · · 2025 · cited 1× · PMID 40898655 · DOI 10.1002/ehf2.15402
Verify or expand the search:
- PubMed search for NCT05475028
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT05752760 — Pilot Study Lp299v Supplementation in Chronic Heart Failure · NA · recruiting
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Other University of Campania Luigi Vanvitelli trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05475028 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Campania Luigi Vanvitelli
- Last refreshed: 26 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05475028.
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