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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05745571
Collaborator
(none)
90
Enrollment
1
Location
4
Arms
59.1
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood sample
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Molecular Pathways of Cardiac Remodellation in Patients With Acute and Chronic Left Ventricular Disfunction (HFrEF)
Actual Study Start Date :
Jan 7, 2019
Actual Primary Completion Date :
Jan 7, 2020
Anticipated Study Completion Date :
Dec 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Patients with acute coronary syndrome

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

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.
Other Names:
  • Molecular pathway and protein

    		•
    Other: Patients with non-ischaemic dilated cardiomyopathy

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

    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.
    Other Names:
  • Molecular pathway and protein

    		•
    Other: Patients diagnosed with STEMI-type ACS

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

    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.
    Other Names:
  • Molecular pathway and protein

    		•
    Other: Controls

    Controls with normal left ventricular contractile function

    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.
    Other Names:
  • Molecular pathway and protein

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione Policlinico Gemelli Roma Italy 00168

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Liuzzo Giovanna, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT05745571
    Other Study ID Numbers:
    • 2291
    First Posted:
    Feb 27, 2023
    Last Update Posted:
    Mar 1, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Liuzzo Giovanna, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Ejection Fraction (EF)
    Sympathetic nervous system (SNS)
    Renin-angiotensin-aldosterone system (RAAS)
    Additional relevant MeSH terms:
    Cardiomyopathies
    Ventricular Dysfunction
    Ventricular Dysfunction, Left

    Study Results

    No Results Posted as of Mar 1, 2023