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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Arterial Hypertension, Heart Failure

Intervention / Treatment
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* Diagnostic Test: Diagnostic tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Identyfication of prognostic factors in VO2max<17 ml/kg/min<br>Selected prognostic factors will be analyzed in patients with VO2max<17 ml/kg/min | Diagnostic Test: Diagnostic tests<br>* 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.<br>|
| Sham Comparator: Identyfication of prognostic factors in VO2max>17 ml/kg/min<br>Selected prognostic factors will be analyzed in patients with VO2max>17 ml/kg/min | Diagnostic Test: Diagnostic tests<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognosis in arterial hypertension | 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. | One year after inclusion in the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, exercise intolerance, troponin, body mass compartments