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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04802369
Enrollment
185
Registered
2021-03-17
Start date
2019-02-01
Completion date
2021-02-28
Last updated
2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Hypertension, Heart Failure

Keywords

hypertension, exercise intolerance, troponin, body mass compartments

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTDiagnostic 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.

Sponsors

Polish Mother Memorial Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prognosis in arterial hypertensionOne year after inclusion in the studyA 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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026