Molecular Pathways of Cardiac Remodellation in Patients With Acute and Chronic Left Ventricular Disfunction (HFrEF)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Study of molecular pathways involved in acute cardiac dysfunction and cardiac remodelling
Study Overview
Brief Summary
Chronic heart failure represents an extremely complex clinical syndrome, defined as the inability of the heart muscle to generate a volume adequate to the metabolic needs of peripheral tissues, or to do so only in the face of high filling pressures intracavity. Heart failure is one of the leading causes of mortality and morbidity in Western countries.
Despite advances in the therapeutic field, the prognosis of patients with heart failure of ischemic and non-ischaemic aetiology still remains unfavorable, with a mortality rate of 50% 5 years after the first hospitalization.Therefore, a deeper understanding of the pathophysiological mechanisms involved in heart failure and adverse ventricular remodeling is essential.
Detailed Description
The study will be interventional, prospective, and single-center. Partecipants will be divided into three groups:
- 30 partecipants admitted to our hospital with the diagnosis of STEMI-type ACS and ejection fraction ≤ 35% on echocardiographic evaluation
- 30 partecipants with non-ischaemic dilated cardiomyopathy and ejection fraction ≤35% on echocardiographic evaluation
- 15 partecipants diagnosed with STEMI-type ACS and ejection fraction > 50% on echocardiographic evaluation
- 15 controls with normal left ventricular contractile function. The study foresees a phase of patient recruitment, in which, in the hours immediately following the blood sampling, the isolation of the PBMCs, their incubation and cytofluorimetric analysis will be carried out and the conservation of the material to be analyzed subsequently by molecular biology and immunochemistry.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •patients admitted to the Gemelli Polyclinic with acute coronary syndromes and heart disease;
- •patients admitted to our polyclinic with the diagnosis of SCA type STEMI and ejection fraction ≤ 35% at echocardiographic evaluation;
- •patients with non-ischemic dilated cardiomyopathy and ejection fraction ≤ 35% at echocardiographic evaluation;
- •patients diagnosed with SCA type STEMI and ejection fraction > 50% at echocardiographic evaluation;
Exclusion Criteria
- •evidence of inflammatory or infectious disease;
- •malignancy, or immunological or hematologic disorders;
- •treatment with anti-inflammatory drugs other than low-dose aspirin;
- •age > 85 years;
- •recent surgery (within one month);
- •advanced chronic kidney disease (eGFR MDRD-4 <30 ml/min./1.73m2).
Arms & Interventions
Patients with acute coronary syndrome
30 patients admitted to our hospital with the diagnosis of STEMI-type ACS and ejection fraction ≤ 35% on echocardiographic evaluation
Intervention: Blood sample (Other)
Patients with non-ischaemic dilated cardiomyopathy
30 patients with non-ischaemic dilated cardiomyopathy and ejection fraction ≤35% on echocardiographic evaluation
Intervention: Blood sample (Other)
Controls
Controls with normal left ventricular contractile function
Intervention: Blood sample (Other)
Patients diagnosed with STEMI-type ACS
Patients diagnosed with STEMI-type ACS and ejection fraction > 50% on echocardiographic evaluation
Intervention: Blood sample (Other)
Outcomes
Primary Outcomes
Study of molecular pathways involved in acute cardiac dysfunction and cardiac remodelling
Time Frame: 10 months
Gene expression assessment of molecular pathways involved in acute cardiac dysfunction and cardiac remodelling underlying reduced ejection fraction heart failure (HFrEF). Evaluation of protein expression of specific markers by means of cytofluorimetric and immunochemical methods, the choice of which will be made after the analysis of the molecular gene patterns most commonly represented in patients with left ventricular contractile dysfunction.The study includes a patient recruitment phase, in which the isolation of PBMCs, their incubation and cytofluorimetric analysis will be carried out in the hours immediately following the blood sampling, and the material will be stored for subsequent analysis by molecular biology and immunochemistry analysis.
Secondary Outcomes
- Experiments to identify possible molecular targets for future studies(6 months)
Investigators
Liuzzo Giovanna
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS