Molecular Pathways of Cardiac Remodellation in Patients With Acute and Chronic Left Ventricular Disfunction (HFrEF)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Heart Failure; Ischemic Cardiomyopathy

Treatments: Other: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT05745571

2291

Details and patient eligibility

About

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.

Full description

The study will be interventional, prospective, and single-center. Partecipants will be divided into three groups:

1. 30 partecipants admitted to our hospital with the diagnosis of STEMI-type ACS and ejection fraction ≤ 35% on echocardiographic evaluation
2. 30 partecipants with non-ischaemic dilated cardiomyopathy and ejection fraction ≤35% on echocardiographic evaluation
3. 15 partecipants diagnosed with STEMI-type ACS and ejection fraction > 50% on echocardiographic evaluation
4. 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.

Enrollment: 90 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 4 patient groups

Patients with acute coronary syndrome

Other group

Description:

30 patients admitted to our hospital with the diagnosis of STEMI-type ACS and ejection fraction ≤ 35% on echocardiographic evaluation

Treatment:

Other: Blood sample

Patients with non-ischaemic dilated cardiomyopathy

Other group

Description:

30 patients with non-ischaemic dilated cardiomyopathy and ejection fraction ≤35% on echocardiographic evaluation

Treatment:

Other: Blood sample

Patients diagnosed with STEMI-type ACS

Other group

Description:

Patients diagnosed with STEMI-type ACS and ejection fraction \> 50% on echocardiographic evaluation

Treatment:

Other: Blood sample

Controls

Other group

Description:

Controls with normal left ventricular contractile function

Treatment:

Other: Blood sample