NCT06213493Completed
Bace1as Role in Heart Failure (BACE1AS-HF)
Role of the BACE1-AS Long Noncoding RNA in Ischemic Heart Failure
Source: ClinicalTrials.gov · Last updated 30 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 630 (actual)
- First submitted
- 10 Jan 2024
- Start date
- 12 Mar 2021
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- IRCCS Policlinico S. Donato
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT06213493
What you commit to
- Study type: Observational
- Participants enrolled: 630
- From 12 Mar 2021 to the primary completion date, 30 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects undergoing chemo/radiotherapy
- Subjects undergoing prolonged steroid therapy
- Previous cardiac surgery including coronary artery bypass grafting
- Any contraindication to implantation of drug-eluting stents (DES)
- Patients with previous documented myocardial infarction;
- Presence of ACS, stroke, transient ischemic attack, major cardiovascular surgery, percutaneous coronary angioplasty or carotid angioplasty in the previous 3 months;
Other illness
- Patients with genetic diseases
- Patients suffering from malignant neoplasm
- Subjects with known active infectious diseases
- Subjects with positive serology for HIV, HBV (not vaccinated), HCV.
- Severe heart valve disease or other conditions requiring cardiac surgery
- Patients with known hypersensitivity or contraindication to any of the following drugs:
- heparin aspirin, clopidogrel, ticlopidine, sirolimus, everolimus.
- Patients suffering from malignant neoplasms or systemic pathologies with a quoad vitam prognosis of less than 1 year;
- Patients suffering from known active infectious diseases;
- End-stage renal disease;
- Patients undergoing cardiac transplantation or on the active list for cardiac transplantation or undergoing LVAD implantation;
- Presence of hemodynamically significant mitral or aortic valve disease except mitral insufficiency due to ventricular dilatation;
Lab values
- LVEF \<30% before PCI
- Patients with known previous cardiomyopathy with LVEF \< 40%
Other
- ESVI \<35 ml/m2
- EF\>40%
- Tempo from E unknown
- Pregnant women
- Subjects with collagenopathies
- Patients with ACS and left ventricular dysfunction 12 months after percutaneous angioplasty
- Total chronic occlusions
- Patients in cardiogenic shock
- Patients with advanced STEMI (\> 48 h from the onset of symptoms/Q waves on ECG) or undergoing fibrinolysis;
- Patients who are unable to express valid informed consent at the time of enrollment
- Pregnant women
- Patients with chronic post-ischemic HF ( recruitment at the Istituti Clinici Scientifici Maugeri Pavia)
- Denial of informed consent;
Who the study is looking for
- left ventricular reconstruction surgery (SVR)
- ESVI \>35 ml/m2
- EF\<40%
- previous anterior transmural infarction
- age 40-75 years
- Age \>18 years
- Patients with ACS (first episode), defined according to the ESC 2017 guidelines \[19\]
- Informed consent to enrollment in the study
- All patients admitted to Rehabilitation Cardiology at the Cardiology Department of ICS Maugeri with a diagnosis of chronic heart failure on an ischemic or "acute" basis due to exacerbation of chronic heart failure due to previous ischemia and whose therapies have been optimized at the moment of enlistment.
- NYHA Class II-III at the time of enlistment;
- Age over 18 years;
- Informed consent signed at the time of enrollment in the study.
Criteria the registry did not label
- Left ventricular biopsies from patients with post-ischemic HF
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Policlinico San Donato Coordinator of this site? Confirm its status | San Donato Milanese | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.