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

NCT04822857 | Completed

• 1 other identifier: PolishMMHRI-BCO.5/2019
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Menopause

Keywords

menopause; hypertension; estradiol; organ damage

Outcome Measures

Primary Outcomes (1)

• AMH

  Anti-Müllerian Hormone

  up to 2 years

Study Arms (2)

1

AMH \> cut-off point

Diagnostic Test: AMH

2

AMH \< cut-off point

Diagnostic Test: AMH

Interventions

AMH DIAGNOSTIC_TEST

The group was divided according to the level of Anti-Müllerian Hormone

1; 2

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women hospitalised in Department of Cardiology and Congenital Malformations of Adults Polish Mother's Memorial Hospital Research Institute

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Polish Mother Memorial Hospital Research Institute: lead

Study Sites (1)

Heart Failure Unit, Department of Cardiology and Congenital Malformations of Adults, Polish Mother's Memorial Hospital Research Institute

Lodz, 93-338, Poland

Location

Related Publications (1)

• 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.

  PMID: 28855169 RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Agata Bielecka-Dąbrowa, MD PhD

  Heart Failure Unit, Department of Cardiology and Congenital Malformations of Adults, Polish Mother's Memorial Hospital Research Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 30, 2021
• Study Start: January 22, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)