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

• Sponsor: Polish Mother Memorial Hospital Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT04802369
• Collaborator: (none)
• Enrollment: 185
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.9
• Patients Per Site Per Month: 7.4

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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.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: Feb 1, 2019
• Actual Primary Completion Date: Jan 28, 2020
• Actual Study Completion Date: Feb 28, 2021

Arms and Interventions

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

Primary Outcome Measures

1. Prognosis in arterial hypertension [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

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Agata Bielecka-Dabrowa, Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Polish Mother Memorial Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT04802369
• Other Study ID Numbers: PMMHRI-BCO.71/2020
• First Posted: Mar 17, 2021
• Last Update Posted: Mar 30, 2021
• Last Verified: Feb 1, 2021

• 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: Hypertension

Study Results

No Results Posted as of Mar 30, 2021