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

Not Applicable

Active, not recruiting

• Conditions: Heart Failure; Ischemic Cardiomyopathy
• Interventions: Other: Blood sample

• Registration Number: NCT05745571
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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:

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.

Study Timeline

• Study Start: 2019-01-07
• Primary Completion: 2020-01-07
• Status Verified: 2023-02
• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-27
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01
• Study Completion: 2023-12-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with non-ischaemic dilated cardiomyopathy	Blood sample	30 patients with non-ischaemic dilated cardiomyopathy and ejection fraction ≤35% on echocardiographic evaluation
Controls	Blood sample	Controls with normal left ventricular contractile function
Patients with acute coronary syndrome	Blood sample	30 patients admitted to our hospital with the diagnosis of STEMI-type ACS and ejection fraction ≤ 35% on echocardiographic evaluation
Patients diagnosed with STEMI-type ACS	Blood sample	Patients diagnosed with STEMI-type ACS and ejection fraction \> 50% on echocardiographic evaluation

Primary Outcome Measures

Name	Time	Method
Study of molecular pathways involved in acute cardiac dysfunction and cardiac remodelling	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 Outcome Measures

Name	Time	Method
Experiments to identify possible molecular targets for future studies	6 months	Carrying out mechanistic experiments to verify the biological significance of altering specific molecular patterns and identifying possible molecular targets for subsequent studies.; For these future studies, it is planned to store material for retrospective analysis by molecular biology and immunochemistry.

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli; 🇮🇹 Roma, Italy