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Completed

NCT Number: NCT04802369

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

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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Key information

Age range

40 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Lodz, 93-338, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic tests

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.

Primary outcomes

  1. Prognosis in arterial hypertension

    Time frame: One year after inclusion in the study

    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.

Sponsors and collaborators

Lead sponsor

Polish Mother Memorial Hospital Research Institute

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 17, 2021
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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