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

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ClinicalTrials.gov Identifier: NCT04802369
Recruitment Status : Completed
First Posted : March 17, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Polish Mother Memorial Hospital Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Arterial Hypertension Heart Failure Diagnostic Test: Diagnostic tests Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Factors and Prognostic Significance of Impaired Exercise Tolerance in Women Over 40 With Arterial Hypertension
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : January 28, 2020
Actual Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Identyfication of prognostic factors in VO2max<17 ml/kg/min
Selected prognostic factors will be analyzed in patients with VO2max<17 ml/kg/min
 Diagnostic Test: 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.
Sham Comparator: Identyfication of prognostic factors in VO2max>17 ml/kg/min
Selected prognostic factors will be analyzed in patients with VO2max>17 ml/kg/min
 Diagnostic Test: 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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04802369


Locations
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Poland
Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute
Łódź, Poland, 93-338
Sponsors and Collaborators
Polish Mother Memorial Hospital Research Institute
Investigators
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Principal Investigator: Agata Bielecka-Dabrowa Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI
More Information
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Publications:
Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; Authors/Task Force Members:. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018 Oct;36(10):1953-2041. doi: 10.1097/HJH.0000000000001940. Erratum in: J Hypertens. 2019 Jan;37(1):226.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Polish Mother Memorial Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04802369    
Other Study ID Numbers: PMMHRI-BCO.71/2020
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Polish Mother Memorial Hospital Research Institute:
hypertension
exercise intolerance
troponin
body mass compartments
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases