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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04802369
• Other study ID #: PMMHRI-BCO.71/2020
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: February 2021
• Source: Polish Mother Memorial Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: February 28, 2021
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Hypertension
• Heart Failure
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Poland	Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Polish Mother Memorial Hospital Research Institute

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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