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

NCT05745571 | Unknown

• 1 other identifier: 2291
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Ischemic Cardiomyopathy

Keywords

Ejection Fraction (EF); Sympathetic nervous system (SNS); Renin-angiotensin-aldosterone system (RAAS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Experiments to identify possible molecular targets for future studies

  6 months

Study Arms (4)

Patients with acute coronary syndrome

OTHER

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

Other: Blood sample

Patients with non-ischaemic dilated cardiomyopathy

OTHER

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

Other: Blood sample

Patients diagnosed with STEMI-type ACS

OTHER

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

Other: Blood sample

Controls

OTHER

Controls with normal left ventricular contractile function

Other: Blood sample

Interventions

Blood sample OTHER

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.

Also known as: Molecular pathway and protein

Controls; Patients diagnosed with STEMI-type ACS; Patients with acute coronary syndrome; Patients with non-ischaemic dilated cardiomyopathy

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Blood Specimen Collection; Proteins

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Our study will be interventional, prospective, and single-center. At the time of enrollment in the study, peripheral blood will be drawn, then patients will be recalled for follow-up visits at 1 and 6 months, during which new venous blood draws will be performed, together with the echocardiographic examination. Patients will undergo the treatment required by the current and most recent guidelines for heart failure and adherence to this study will not involve any modification of the current therapy.

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 27, 2023
• Study Start: January 7, 2019
• Primary Completion: January 7, 2020
• Study Completion: December 10, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)