Clinical trial NCT04802369: Factors and Prognostic Significance of Impaired Exercise Tolerance in Women Over 40 With Arterial Hypertension
Official title: Factors and Prognostic Significance of Impaired Exercise Tolerance in Women Over 40 With Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Hypertension
Heart Failure
Keywords: hypertension
exercise intolerance
troponin
body mass compartments
Lead sponsor: Polish Mother Memorial Hospital Research Institute
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 185
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Prognosis in arterial hypertension
timeFrame: One year after inclusion in the study
Secondary outcomes:
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute
Study officials:
affiliation: Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI
name: Agata Bielecka-Dabrowa
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.