Ignite Creation Date:
2024-05-06 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03389386
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2017-12-19
Brief Title:
Serum Catestatin Expression and Cardiometabolic Parameters in Patients With Congestive Heart Failure
Sponsor:
Josko Bozic
Organization:
University Hospital of Split
Study Overview
Official Title:
Serum Catestatin Expression and Cardiometabolic Parameters in Patients With Congestive Heart Failure
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CATSTAT-HF
Brief 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 andor 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 hematologicbiochemistry 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
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 andor 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 hematologicbiochemistry 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None