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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-02-28

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.

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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.

Conditions

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Arterial Hypertension Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

Diagnostic tests

Intervention Type DIAGNOSTIC_TEST

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.

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

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

Group Type SHAM_COMPARATOR

Diagnostic tests

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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Diagnostic tests

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.

Intervention Type DIAGNOSTIC_TEST

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No