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

Heart Failure Clinical Trial

— HFrEF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05745571
• Other study ID #: 2291
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: December 10, 2023

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 10, 2023
• Est. primary completion date: January 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Ischemic Cardiomyopathy
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Other:
• Blood sample
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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study of molecular pathways involved in acute cardiac dysfunction and cardiac remodelling	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.	10 months
Secondary	Experiments to identify possible molecular targets for future studies	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.	6 months