Clinical trial NCT05745571: Molecular Pathways of Cardiac Remodellation in Patients With Acute and Chronic Left Ventricular Disfunction
Official title: Molecular Pathways of Cardiac Remodellation in Patients With Acute and Chronic Left Ventricular Disfunction (HFrEF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Ischemic Cardiomyopathy
Keywords: Ejection Fraction (EF)
Sympathetic nervous system (SNS)
Renin-angiotensin-aldosterone system (RAAS)
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 90
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Study of molecular pathways involved in acute cardiac dysfunction and cardiac remodelling
timeFrame: 10 months
Secondary outcomes:
measure: Experiments to identify possible molecular targets for future studies
timeFrame: 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli
Study officials:
References: