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临床试验/NCT04822857
NCT04822857已完成不适用

The Impact of Menopause on the Development of Heart Failure and Organ Damage of Hypertension

Polish Mother Memorial Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2019年1月22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
86
试验地点
1
主要终点
AMH

研究概览

简要总结

Introduction: The average age of menopause in the Polish population is around 50 years. After the occurrence of the last menstruation in the woman's body there are series of hormonal changes that may result in the emergence of new diseases, i.e. osteoporosis or ischemic heart disease. Hypertension is the most important cardiovascular risk factor affecting morbidity and mortality due to cardiovascular disease. It is estimated that there are as many as 34% of adult Poles. The incidence of hypertension increases with age in both women and men, and significantly greater increases are observed in perimenopausal women. An equally important and growing health and economic problem in Poland is heart failure. It is estimated that up to 700,000 patients in our country are struggling with this disease, and the proportion of women in this group is constantly growing. This is the third reason for the death of women in Poland, causing more deaths than cancer. The influence of menopause on the occurrence of heart failure in a group of women with controlled hypertension remains unclear and is the subject of ongoing research. Similarly, there is still no convincing data on the increased risk of organ complications of arterial hypertension in the group of postmenopausal women.

The aim of the study is to assess the effect of menopause on myocardial function indexes, haemodynamic parameters and body mass composition in women aged> 40 years.

Material: about 100 women hospitalized in the Department of Cardiology and Congenital Heart Diseases of Adults > 40 years of age will be enrolled in the study. with controlled hypertension. The population will be divided into two groups: I: 50 women before the onset of menopause and II group: 50 women ≥ 1 year after the onset of menopause.

Methods: Basic laboratory tests and concentrations of ADMA, NT-proBNP, neprilysin, estradiol and FSH will be performed in patients. The other planned examinations are: full clinical examination with BMI assessment, resting ECG test, full echocardiography using tissue doppler, volume and function of the left atrium and vascular stiffness index assessed using the sphygmocor device. In addition, it is planned to analyze the composition of body mass using electrical bioimpedance, intima-media complex measurement and spiroergometric study. One year after the inclusion in the study, a telephone interview will be carried out with the patients, with particular attention to the diagnosed diseases / onset of intervention: heart failure, diabetes, atrial fibrillation, the need for coronary angiography or rehospitalisation. The collected data will be statistically processed.

New values: Studies carried out as part of this work will supplement the current knowledge on the impact of menopause in the population of women with hypertension on the risk of heart failure and complications of organ hypertension. Thanks to the observed relationships, it will be possible to early start the appropriate diagnostic procedure, the selection of personalized treatment and the development of a model of cardiac care for women in the perimenopausal period, and thus improve quality and extend their life.

详细描述

Introduction:

The average age of menopause in the Polish population is around 50 years. After the last menstruation a number of hormonal changes occur in the female body: estrogen, ovarian androgens (testosterone, androstenedione) and adrenal ones (DHEA, DHEAS), progesterone, growth hormone and insulin-like growth factors decrease. The concentration of gonadotropins gradually increases. These hormonal changes may result in the appearance of osteoporosis, climacteric syndrome, depression, changes in the structure of the skin or stress urinary incontinence in women. It has been documented that the risk of ischemic heart disease increases significantly after the onset of menopause which is reflected in the lowering of estrogen levels. These hormones are responsible for changes both in the lipid profile and in the vascular wall which significantly increases the likelihood of atherosclerotic plaque formation.

Hypertension is the most important cardiovascular risk factor affecting morbidity and mortality due to cardiovascular disease. It is estimated that there are as many as 34% of adult Poles. The incidence of hypertension increases with age in both women and men and significantly greater increases are observed in perimenopausal women.

An equally important and growing health and economic problem in Poland is heart failure. It is estimated that up to 700,000 patients in our country are struggling with this disease and the proportion of women in this group is constantly growing. This is the third reason for the death of women in Poland causing more deaths than cancer.

The influence of menopause on the occurrence of heart failure in a group of women with controlled hypertension remains unclear and is the subject of ongoing research. Similarly, there is still no convincing data on the increased risk of organ complications of arterial hypertension in the group of postmenopausal women.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • About 100 women aged> 40 years will be included in the study with diagnosed pharmacologically controlled hypertension, including:
  • Group I-about 50 women > 40 years before the onset of menopause Group II - approximately 50 women > 1 year after the onset of menopause

排除标准

  • unstable hypertension;
  • diagnosed heart failure or typical symptoms of heart failure;
  • documented: hyperandrogenism, hyperendogenism, insulin resistance, premature ovarian failure, polycystic ovary syndrome;
  • previous myocardial infarction;
  • diagnosed cardiomyopathy (hypertrophic, dilated, restrictive, puerperal, tachyarrhythmic);
  • storage diseases;
  • stroke, TIA, an intracerebral bleeding;
  • severe hyperthyroidism or hypothyroidism;
  • pregnancy or lactation;
  • chronic kidney disease in stage IV, V according to NKF and patients undergoing dialysis;
  • documented cancer process;
  • patient's inability to cooperate and / or give informed consent not to participate in a research;
  • alcohol and drug abuse;
  • active autoimmune disease;
  • taking immunosuppressive, cytostatic drugs, glucocorticoids or antiretroviral drugs;
  • bone marrow transplant or other organ transplantation, treatment with blood products during the last 6 months;
  • active systemic infection;
  • HBV, HCV or HIV infection or a positive result for the presence of HbS antigen or anti-HCV antibodies;
  • surgery or serious injury in the last month;
  • vaccination interview in the last 3 months;
  • patients who have not expressed their informed consent to participate in the study

结局指标

主要结局

AMH

时间窗: up to 2 years

Anti-Müllerian Hormone

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
Principal Investigator
主要研究者

Kamil Janikowski

Medical Doctor

Polish Mother Memorial Hospital Research Institute

研究点 (1)

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