NCT03268135 Heart Failure and Aortic Stenosis Transcriptome
| NCT ID | NCT03268135 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Policlinico S. Donato |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2016-05-30 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2016-05-30 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is aimed to investigate the global transcriptome in order to determine the expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro noncoding-RNAs (miRNAs) in heart failure (HF) and in aortic stenosis (AS). The aim is to clarify their role in cardiac disease pathogenesis, as well as their potential as biomarkers. To this purpose, both tissue and blood specimens will be collected and patients will be compared to individuals not affected by cardiovascular diseases.
Eligibility 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
Contact & Investigator
Fabio Martelli, Dr
PRINCIPAL INVESTIGATOR
IRCCS Policlinico S. Donato
Frequently Asked Questions
Who can join the NCT03268135 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03268135 currently recruiting?
Yes, NCT03268135 is actively recruiting participants. Contact the research team at fabio.martelli@grupposandonato.it for enrollment information.
Where is the NCT03268135 trial being conducted?
This trial is being conducted at San Donato Milanese, Italy, Milan, Italy.
Who is sponsoring the NCT03268135 clinical trial?
NCT03268135 is sponsored by IRCCS Policlinico S. Donato. The principal investigator is Fabio Martelli, Dr at IRCCS Policlinico S. Donato. The trial plans to enroll 500 participants.
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