Investigating RNA profiles in heart failure and aortic stenosis
Study of the Transcriptomic Alterations in Heart Failure and Aortic Stenosis
IRCCS Policlinico S. Donato · NCT03268135
This study is trying to see how certain RNA molecules in the blood and heart tissue of people with heart failure and aortic stenosis might help us understand their heart problems better and identify new ways to diagnose them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato (other) |
| Locations | 2 sites (San Donato Milanese, Milan and 1 other locations) |
| Trial ID | NCT03268135 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the global transcriptome to identify the expression profiles of messenger RNAs (mRNAs), long noncoding RNAs (lncRNAs), and micro RNAs (miRNAs) in patients with heart failure and aortic stenosis. Researchers will collect plasma and cardiac tissue specimens from participants, including those with both end-stage and non-end-stage heart failure, as well as patients undergoing aortic valve replacement. The study seeks to clarify the role of these RNA molecules in cardiac disease pathogenesis and their potential as biomarkers by comparing affected individuals to those without cardiovascular diseases.
Who should consider this trial
Good fit: Ideal candidates include adults aged 40-75 with either non-end-stage or end-stage heart failure, or those with aortic stenosis requiring valve replacement.
Not a fit: Patients with conditions such as early-stage heart failure, certain genetic diseases, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of new biomarkers for heart failure and aortic stenosis, improving diagnosis and treatment strategies.
How similar studies have performed: While the approach of investigating RNA profiles in cardiac diseases is gaining traction, this specific study's focus on both heart failure and aortic stenosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Non end-stage heart failure * left ventricle restoration surgery (SVR) * End Systolic Volume Index (ESVI) \>35 ml/m2 * Ejection Fraction (EF)\<40% * previous transmural anterior myocardial infarction (MI) * age: 40-75 2. End-stage heart failure * left ventricle assisted device (LVAD) surgery * age: 40-75 * Ejection Fraction (EF) \<25% * End Systolic Volume Index (ESVI)≥60 ml/m2 3. Aortic Stenosis * aortic valve replacement * intracardial pressure difference \>40 mmHg * septal diameter ≥1.3 cm Exclusion Criteria: 1. Non end-stage heart failure * End Systolic Volume Index (ESVI)\<35 ml/m2 * Ejection Fraction (EF)\>40% * Time from MI unknown * Pregnancy * Other genetic diseases * Neoplasms * Collagenopathies * Chemo/radiotherapy * Prolonged use of corticosteroids * Infections * Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive 2. End-stage heart failure * EF\>25% * Time from MI unknown * Pregnancy * Other genetic diseases * Neoplasms * Collagenopathies * Chemo/radiotherapy * Prolonged use of corticosteroids * Infections * Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive 3. Aortic Stenosis * coronaropathies * Pregnancy * Other genetic diseases * Neoplasms * Collagenopathies * Chemo/radiotherapy * Prolonged use of corticosteroids * Infections * Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive
Where this trial is running
San Donato Milanese, Milan and 1 other locations
- Irccs Policlinico San Donato — San Donato Milanese, Milan, Italy (RECRUITING)
- Ospedale San Raffaele — Milan, Italy (RECRUITING)
Study contacts
- Principal investigator: Fabio Martelli, Dr — IRCCS Policlinico S. Donato
- Study coordinator: Fabio Martelli, Dr
- Email: fabio.martelli@grupposandonato.it
- Phone: +39 02 26437762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Aortic Stenosis, miRNA, lncRNAs, transcriptome, heart failure, aortic stenosis, biomarkers