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临床试验/NCT03389386
NCT03389386已完成不适用

Serum Catestatin Expression and Cardiometabolic Parameters in Patients With Congestive Heart Failure

Josko Bozic1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Catestatin levels in blood serum

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
35 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adult men and women, 35-90 years of age
  • Patients with clinically documented diagnosis of congestive heart failure (CHF) according to New York Heart Association (NYHA) functional classification (II-IV)

排除标准

  • Age criteria:
  • Persons below legal age (<18 years)
  • Adults younger than 35 years of age
  • Adults older than 90 years of age
  • Participants with following conditions:
  • Diabetes mellitus type I
  • Documented or newly-established severe valvular or pericardial disease
  • Infiltrative or hypertrophic cardiomyopathy
  • Primary pulmonary disease or cor pulmonale
  • Active malignant disease and/or active infectious disease
  • Significant systemic autoimmune disease
  • A positive history of excessive alcohol, drug, narcotics, and sedative consumption
  • Significant psychiatric or neurologic condition
  • Immunocompromised patients or patients that are under immunosuppressive treatment
  • Significant liver or renal insufficiency (primary renal or hepatic disease)
  • Hemorrhagic diathesis or significant coagulopathy
  • Positive recent history of cancer chemotherapeutic drug use
  • A positive history of acute coronary syndrome or stroke within 3 months prior to study enrollment

结局指标

主要结局

Catestatin levels in blood serum

时间窗: 3 months

The goal is to determine and compare serum catestatin levels in patients with congestive heart failure, stratified by the left ventricular ejection fraction (LVEF) in three groups: reduced, mid-range, and preserved ejection fraction (HFrEF, HFmrEF, HFpEF). Furthermore, catestatin plasma levels will be compared between patients with congestive heart failure and healthy volunteers.

次要结局

  • Relationship of serum catestatin levels with the echocardiographic parameters of cardiac function(3 months)
  • Relationship of serum catestatin levels with the selected laboratory indices(3 months)

研究者

发起方
Josko Bozic
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Josko Bozic

Assistant Professor

University Hospital of Split

研究点 (1)

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