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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Arterial Hypertension
• Intervention / Treatment: Diagnostic test: Diagnostic tests

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 Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Łódź, Poland, 93-338
    • Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Polish Mother Memorial Hospital Research Institute
• Investigators: Principal Investigator: Agata Bielecka-Dabrowa, Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI

Publications and helpful links

General 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.
• Bielecka-Dabrowa A, Gryglewska K, Sakowicz A, Rybak M, Janikowski K, Banach M. Obesity and Body Mass Components Influence Exercise Tolerance and the Course of Hypertension in Perimenopausal Women. J Cardiovasc Dev Dis. 2022 Jul 27;9(8):238. doi: 10.3390/jcdd9080238.
• Bielecka-Dabrowa A, Gryglewska K, Sakowicz A, von Haehling S, Janikowski K, Maciejewski M, Banach M. Factors and Prognostic Significance of Impaired Exercise Tolerance in Women over 40 with Arterial Hypertension. J Pers Med. 2021 Jul 30;11(8):759. doi: 10.3390/jpm11080759.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): January 28, 2020
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: hypertension; troponin; exercise intolerance; body mass compartments
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: PMMHRI-BCO.71/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No