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Sponsor study identifier
observational
86
1 country
1
Study Start
January 22, 2019
Actual (reported)Primary Completion
December 30, 2019
Actual (reported)Study Completion
December 30, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2020
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 22, 2019
Actual (reported)December 30, 2019
Actual (reported)December 30, 2020
Actual (reported)March 24, 2021
Actual (reported)March 30, 2021
Actual (reported)AMH
Anti-Müllerian Hormone
up to 2 years
AMH \> cut-off point
AMH \< cut-off point
The group was divided according to the level of Anti-Müllerian Hormone
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Women hospitalised in Department of Cardiology and Congenital Malformations of Adults Polish Mother's Memorial Hospital Research Institute
Heart Failure Unit, Department of Cardiology and Congenital Malformations of Adults, Polish Mother's Memorial Hospital Research Institute
Lodz, 93-338, Poland
Wang N, Shao H, Chen Y, Xia F, Chi C, Li Q, Han B, Teng Y, Lu Y. Follicle-Stimulating Hormone, Its Association with Cardiometabolic Risk Factors, and 10-Year Risk of Cardiovascular Disease in Postmenopausal Women. J Am Heart Assoc. 2017 Aug 30;6(9):e005918. doi: 10.1161/JAHA.117.005918.
Agata Bielecka-Dąbrowa, MD PhD
Heart Failure Unit, Department of Cardiology and Congenital Malformations of Adults, Polish Mother's Memorial Hospital Research Institute
86 participants (actual enrollment reported by the registry).
First Submitted
March 24, 2021
First Posted
March 30, 2021
Study Start
January 22, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 30, 2019
Actual (reported)Study Completion
December 30, 2020
Actual (reported)Last Updated
April 1, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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