Bace1as Role in Heart Failure (BACE1AS-HF)

NCT06213493 | Completed DMC

• 1 other identifier: BACE1AS_HF- RF-2019-12368521
• Study Type: observational
• Target: 630
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this project is 1) to explore the clinical relevance of BACE1-AS and BACE1 as therapeutic targets and 2) to evaluate their potentiality as biomarkers in ischemic heart failure (HF). The first aim will be studied by validating in left ventricle biopsies in patients with post-ischemic heart failure the transcriptome and DNA methylation status data obtained in cell lines where the expression of BACE1-AS has been modulated. The investigation of BACE1-AS and BACE1 as biomarkers will be obtained by using peripheral blood mononuclear cells (PBMCs) from patients with acute coronary syndrome (ACS) treated with percutaneous angioplasty (PCI) procedure and undergoing to left ventricular remodeling. Furthermore, PBMCs from patients with chronic ischemic HF recruited from the Istituti Clinici Scientifici Maugeri Pavia will be also used. From the data obtained from these patients and from non-decompensated subjects, the levels of BACE1-AS and BACE1 in the blood will be measured and correlated with each other and with β-amyloid levels (βA), as well as with clinically relevant parameters.

Conditions

Heart Failure; Acute Coronary Syndrome

Keywords

long noncoding RNA; heart failure; acute coronary syndrome; biomarkers

Outcome Measures

Primary Outcomes (3)

• Cardiac tissutal RNAs expression

  The RNAs cardiac tissutal expression of non- and end-stage heart failure patients compared to controls

  From year 1 to year 3

• Peripheral blood RNAs expression in ACS

  The RNAs expression in peripheral blood mononuclear cells of acute coronary syndrome patients treated with percutaneous angioplasty and remodelling compared to controls

  From year 1 to year 3

• Peripheral blood RNAs expression in heart failure

  The RNAs expression in peripheral blood mononuclear cells of heart failure patients compared to controls

  From year 1 to year 3

Study Arms (4)

Non end-stage heart failure

Measurement of tissutal RNAs in non end-stage heart failure patients undergoing to left ventricle reconstruction

Diagnostic Test: measurement of RNAs

ACS patients

Measurement of circulating RNAs in acute coronary syndrome (ACS) patients treated with percutaneous angioplasty and undergoing to ventricle remodelling

Diagnostic Test: measurement of RNAs

HF patients

Measurement of circulating RNAs in heart failure patients

Diagnostic Test: measurement of RNAs

Controls

Measurement of RNAs in individuals not affected by cardiovascular diseases

Diagnostic Test: measurement of RNAs

Interventions

measurement of RNAs DIAGNOSTIC_TEST

RNAs will be measured in heart tissues and in peripheral blood mononuclear cells

ACS patients; Controls; HF patients; Non end-stage heart failure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. Left ventricular biopsies from patients with post-ischemic HF. Left ventricular tissue fragments from patients with post-ischemic HF undergoing to left ventricular reconstruction (SVR) will be used 2. Patients with acute coronary syndrome and left ventricular dysfunction 12 months after percutaneous angioplasty Control group will be represented by patients suffering from unstable angina. 3. Patients with chronic post-ischemic HF (recruitment at the Istituti Clinici Scientifici Maugeri Pavia ICS) All patients admitted with a diagnosis of chronic heart failure or an ischemic or "acute" basis due to exacerbation.

You may qualify if:

• left ventricular reconstruction surgery (SVR)
• ESVI \>35 ml/m2
• EF\<40%
• previous anterior transmural infarction
• age 40-75 years

You may not qualify if:

• ESVI \<35 ml/m2
• EF\>40%
• Tempo from E unknown
• Pregnant women
• Patients with genetic diseases
• Patients suffering from malignant neoplasm
• Subjects with collagenopathies
• Subjects undergoing chemo/radiotherapy
• Subjects undergoing prolonged steroid therapy
• Subjects with known active infectious diseases
• Subjects with positive serology for HIV, HBV (not vaccinated), HCV.
• Patients with ACS and left ventricular dysfunction 12 months after percutaneous angioplasty
• Age \>18 years
• Patients with ACS (first episode), defined according to the ESC 2017 guidelines \[19\]
• Informed consent to enrollment in the study

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead
• Istituti Clinici Scientifici Maugeri di Pavia: collaborator

Study Sites (1)

Irccs Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, tissue

MeSH Terms

Conditions

Heart Failure; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases

Study Officials

• Fabio Martelli, PhD

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Molecular Cardiology Laboratory

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 19, 2024
• Study Start: March 12, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)