Serum Catestatin Expression and Cardiometabolic Parameters in Patients With Congestive Heart Failure
Conditions: Heart Failure，Congestive
Sponsor: Josko Bozic

CATSTAT-HF 
 
Official Title of the Study: 
Serum Catestatin Expression and Cardiometabolic Parameters in Patients With 
Congestive Heart Failure (CATSTAT-HF) 
NCT number: 
NCT03389386 
 
 
Date of the document: 
April 15th 2019 
 
Study organizations: 
University of Split School of Medicine 
University Hospital of Split 
 
 
            
 

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STUDY PROTOCOL 
 
Study location (site): Clinic for cardiovascular diseases, University Hospital of Split (UHSplit), 
Split, Croatia 
Anticipated start date: Jan 2018 
Anticipated end date: April 2019 
Ethical Approval: This study protocol has been independently reviewed and separately approved 
by the Ethics Committee of the University of Split School of Medicine and the Ethics Committee 
of the University Hospital of Split and as such has been submitted for the registration at the 
Clinical Trials registry http://ClinicalTrials.gov where it was accepted and initially released on 
December 19th 2017. 
Approval number: 2181-147-01/06/M.S.-17-2 
Participant recruitment: 
Participation in this study will be exclusively on a volunteer basis. Every eligible participant 
will receive a printed material containing information about the study and an written Informed 
Consent formular in Croatian language will be obtained from every subject willing to participate 
in the study. Participants will be divided in two groups: a) patients being diagnosed with 
congestive heart failure (NYHA II-IV) and b) healthy volunteers (matched controls). 
Procedures: 
Every patient that has received information about the study and agreed to sign the 
written Informed Consent in Croatian language will undergo non-invasive and pain-free 
procedures that will include clinical examination performed by the qualified medical doctor 
and/or licensed cardiologist and obtained clinical/physical examination/medical history variables 
will be recorded in the study formular. 
Furthermore, antecubital venous blood sampling in each patient will be undertaken by the 
staff nurse for each participant enrolled in the study. These blood samples will then be used for 
the analysis of the laboratory parameters at the licensed University Hospital of Split Department 

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of Laboratory Diagnostics. Laboratory parameters of interest are further explained in the text 
below (please refer to „Peripheral blood sampling...“ section on page 4). 
 Clinical examination will include the following: 
- 
Recording of the medical history for each participant 
- 
Basic anthropometric measurements: age, sex, body mass, height, body mass index 
(BMI), neck/waist/hip circumference 
- 
Determination of smoking status: current smoker, ex smoker, non-smoker 
- 
Recording of comorbidites for each patient: diabetes mellitus, dyslipidemia, arterial 
hypertension, chronic obstructive pulmonary disease and/or asthma, peripheral 
artery disease, atrial fibrillation, valvular heart disease, coronary artery disease and 
other comorbidities of interest 
- 
ECG records at admission and/or during index hospitalization 
- 
Recording of following clinical variables for chronic heart failure patients: number 
of previous hospitalization due to heart failure decompensation (if the pariticipant 
was hospitalized), medical history of prior cardiac surgeries or coronary interventions, 
heart failure functional classification according to New York Heart Association (NYHA) 
graded from II to IV and all left-ventricular ejection fractions (ranging from reduced to 
preserved), time of heart failure diagnosis (less than 18 months or not), medical 
history of acute coronary syndrome (unstable angina, NSTEMI, STEMI), medical 
history of stroke, current medication usage (specific entries – antiarryhtmics, 
antihypertensives, diuretics, mineralocorticoid antagonists, digoxin, anticoagulant 
and/or antiplatelet therapy, special drugs such as sacubitril/valsartan or antianginals 
such as ivabradine, ranolazine, trimetazidine, etc.) 
- 
Calculation of relevant risk stratification scores for HF patients enrolled in the study 
such as MAGGIC risk score, Seattle Heart Failure Model (SHFM), GWTG HF, Seattle 
Proportional Risk Model (SPRM) and similar IN ADDITION to CHA2DS2-VASc and HAS-
BLED scores for the subset of HF patients with a concomitant atrial fibrillation (AF) 
 

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 Transthoracic echocardiographic (TTE) examination performed by licensed cardiologist-
ultrasonographer that will examine following variables in every participant:  
- 
Left-ventricular ejection fraction (LVEF, %) 
- 
End-diastolic dimensions of left ventricle (LVEDd, mm) 
- 
End-diastolic volume of left ventricle (EDV, mL) 
- 
End-systolic volume of left ventricle (ESV, mL) 
- 
Ratio of peak flow velocity in early diastole and late diastole (E/A ratio) 
- 
Left-ventricular mass and left-ventricular mass index (LVMI) 
- 
Parameters that will be recorded in selected patients for the subset analysis 
o Global longitudinal strain (GLS) 
o Right-ventricular free wall strain (RVFW strain) 
o Right-ventricular systolic function 
o Other TTE parameters of interest 
 
 Peripheral blood sampling from the antecubital vein – maximum of 22 mL will be 
obtained from each individual participant from both groups and following laboratory 
variables will be analyzed from blood samples: 
- 
Catestatin serum levels 
- 
Complete blood count, differential blood count 
- 
Coagulation panel (PT, APTT) 
- 
NT-proBNP 
- 
Cardiac hs-Troponin-I (hs-cTnI) 
- 
C-reactive Protein (CRP) 
- 
Creatinine, Urea, BUN 
- 
Electrolytes – Sodium, Potassium, Calcium, Magnesium 
- 
Lipid profile – total cholesterol, LDL-c, HDL-c, triglycerides 
- 
Other biochemical/blood parameters of interest 
 

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Prospective case-controlled study – CATSTAT-HF 
Conducted at the University Hospital of Split 
 
 
 
Pool of available participants for 
the study 
Non-probabilistic sampling 
 Exclusion criteria 
 Inclusion criteria 
1. Basic anthropometric parameters 
2. Clinical parameters of each 
participant (medical history and 
physical examination) 
3. Transthoracic echocardiography 
and basic hemodynamic 
parameters 
4. Peripheral blood drawing and 
respective laboratory analysis 
90 patients with documented heart failure 
(Total left ventricular ejection fraction spectrum 
including LVEF <40%, 40-49%, ≥50 %) 
1. Making of individual electronic 
and paper record for each 
enrolled participant 
2. Noting the loss to follow-up 
3. Noting the attrition rate 
Healthy volunteers (matched controls) 
Total N= 30 
Prospective consecutive enrollment in 3:1 fashion 
(HF patients: healthy volunteers) 
Statistical and data analysis 
Measurements 
Total N of participants = 120 
Study 
inclusion/exclusion  
Study start: Jan 2018 
Study end: Jan 2019 
RESULTS