Serum Catestatin Expression and Cardiometabolic Parameters in Patients With Congestive Heart Failure
Condition: Heart Failure，Congestive
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The congestive heart failure (HF) is a condition associated with substantial morbidity,
      mortality, and high healthcare expenditures. From the pathophysiological standpoint, several
      mechanisms contribute to the progression and dysfunction of the failing heart such as an
      increased hemodynamic overload, impaired myocyte calcium cycling, upregulated apoptotic
      activity, deficient or increased production of extracellular matrix, genetic predilections
      and, finally, excessive neurohumoral stimulation. The vasoactive neurohumoral systems such as
      sympathetic nervous system, renin-angiotensin-aldosterone system (RAAS) and arginine
      vasopressin (AVP) system all play a role in maintaining volume and circulatory homeostasis in
      the situation of impaired cardiac output.

      Catestatin (CST), on another hand, is a novel endogenous peptide cleaved from chromogranin A
      (CgA) that is involved in the regulation of cardiac function and arterial blood pressure. The
      role of this peptide is to elicit potent catecholamine release-inhibitory activity by acting
      at the level of the nicotinic acetylcholine receptors. Therefore, the main hypothesis of this
      study is that the observed serum CST levels will reflect the degree of neurohormonal
      activation in HF, showing a significant relationship with the degree of disease severity as
      measured by relevant functional classifications (such as NYHA class and/or similar).
      Secondly, investigators expect to detect correlation of catestatin serum levels with the
      established risk stratification scores in HF and with the echocardiographic parameters of the
      ventricular function, both in terms of systolic and diastolic cardiac function. Parameters of
      inflammation, NT-proBNP, hs-cTnI, renal function parameters, and basic
      hematologic/biochemistry indices from peripheral blood will also be obtained and analyzed for
      all study participants.

      Furthermore, according to the latest European Society of Cardiology (ESC) guidelines for the
      diagnosis and treatment of acute and chronic HF, participants with established congestive HF
      and the whole spectrum of left ventricular ejection fractions ranging from <40% to ≥50% will
      be included in the study.

      Finally, all echocardiographic and laboratory parameters obtained from peripheral blood will
      be recorded and compared with respective healthy and matched control participants while
      participants diagnosed with HF will additionally be analyzed for potential differences
      between subgroups of interest.
    


Intervention name(s): Blood withdrawal for laboratory analysis; Standard-of-care treatment; Transthoracic echocardiography (TTE)
Intervention type(s): Diagnostic Test; Other; Diagnostic Test
Intervention description(s): Participants in this study will have their peripheral blood sampled from the cubital vein and the total volume withdrawn for the purposes of this study will be no more than 22 mL per person.
Parameters of interest in the laboratory analysis will include serum catestatin levels, NT-proBNP levels, hs-cTnI, parameters of inflammation and renal function as well as standard biochemistry and complete blood count (CBC) panels.; Patients diagnosed with chronic heart failure will receive optimal standards of care in terms of pharmacologic management, according to their current clinical condition.; Participants from both groups will undergo transthoracic echocardiography examination that will measure established hemodynamic parameters of systolic and diastolic cardiac function as well as parameters of LV and RV strain in the selected subset of patients.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in the Congestive Heart Failure group will be consecutively enrolled from the pool
        of patients that will present with signs and symptoms of heart failure at Internal Medicine
        Emergency Department (ED) of the University Hospital of Split and will be subsequently
        admitted and hospitalized with working diagnosis of decompensated heart failure (I50.0).
        Patients that meet eligibility criteria and do not fulfill any of the excluding criteria
        will be further included in the study.

        Participants in the Healthy Control group will be enrolled from the sample of healthy
        residents of Split or nearby communities that meet the eligibility criteria for the study
        inclusion.
      
Biospecimen description: 
      Full blood obtained from the antecubital vein.
    
Keywords: Congestive Heart Failure; Catestatin; Chromogranin A; Echocardiography; Biomarkers; Ventricular Dysfunction, Left; Comorbidity