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临床试验/NCT04802369
NCT04802369已完成不适用

Factors and Prognostic Significance of Impaired Exercise Tolerance in Women Over 40 With Arterial Hypertension

Polish Mother Memorial Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2019年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
185
试验地点
1
主要终点
Prognosis in arterial hypertension

研究概览

简要总结

The subject of the study is evaluation of factors affecting to exercise intolerance in spiroergometry in women over 40 years of age with hypertension and association and relationship between the parameters of physical performance and prognosis in this group of patients.

详细描述

The 185 women over 40 years of age hospitalized for arterial hypertension in the Department of Cardiology will be included in the study, including: the study group who demonstrated maximal oxygen consumption measured during incremental exercise indexed per kilogram - VO2max<17 ml/kg/min and a second group who presented VO2max>17 ml/min/kg.Selected prognostic factors will be analyzed, among others: demographic data of the patient, physical examination, symptoms, etiology and history of arterial hypertension, co-morbidities, results of selected laboratory tests, selected electrocardiographic and echocardiographic data, patient's cooperation with the doctor, treatment applied, parameters in the spiroergometric study, non-invasive assessment for central arterial pressure waveform analysis and body mass analysis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Age equal to or older than 40 years
  • •Arterial hypertension (HA) diagnosed according to the 2018 European Society of Cardiology (ESC) guidelines of HA [1]
  • •Current HA hospitalization

排除标准

  • •Severe hypertension
  • •Diagnosis of heart failure or typical symptomatic heart failure
  • •Left ventricular ejection fraction (LVEF) <50%
  • •Documented: hyperandrogenism, hyperestrogenism, insulin resistance, premature ovarian failure, polycystic ovary syndrome
  • •Past myocardial infarction
  • •Diagnosis of cardiomyopathy (hypertrophic, dilated, restrictive, peripartum, arrhythmogenic)
  • •Lysosomal storage disorders
  • •Stroke, transient ischemic attack, Intracerebral hemorrhage in medical history
  • •Severe hyper- and hypothyroidism
  • •Pregnancy and lactation
  • •Chronic kidney disease (IV, V stadium according to National Kidney Foundation) and dialysis treatment
  • •Documented neoplastic process
  • •The patient's inability to cooperate and/or provide informed consent to participate in a research
  • •Alcohol and drug abuse
  • •Active autoimmune disease
  • •Treatment using immunosuppressants, cytostatic drugs, glucocorticosteroids, or antiretroviral drugs
  • •A history of bone marrow transplant or other organ transplant, treatment with blood products within the last 6 months
  • •Active systemic infection
  • •Hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) carrier or positive for hepatitis B surface antigen (HBSAg) or antibodies to HCV
  • •Surgery or serious injury within the last month
  • •Patients who did not express their informed consent to participate in the study

研究组 & 干预措施

Identyfication of prognostic factors in VO2max<17 ml/kg/min

Active Comparator

Selected prognostic factors will be analyzed in patients with VO2max<17 ml/kg/min

干预措施: Diagnostic tests (Diagnostic Test)

Identyfication of prognostic factors in VO2max>17 ml/kg/min

Sham Comparator

Selected prognostic factors will be analyzed in patients with VO2max>17 ml/kg/min

干预措施: Diagnostic tests (Diagnostic Test)

结局指标

主要结局

Prognosis in arterial hypertension

时间窗: One year after inclusion in the study

A telephone interview will be conducted with patients. These will be questions about death, cardiovascular adverse events (myocardial infarction, acute coronary syndrome), occurrence of symptoms of heart failure, diabetes mellitus, atrial fibrillation, necessity performing coronary angiography or re-hospitalization.

次要结局

未报告次要终点

研究者

发起方
Polish Mother Memorial Hospital Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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