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

P

Polish Mother Memorial Hospital Research Institute

Status

Completed

Conditions

Arterial Hypertension
Heart Failure

Treatments

Diagnostic Test: Diagnostic tests

Study type

Interventional

Funder types

Other

Identifiers

NCT04802369
PMMHRI-BCO.71/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

185 patients

Sex

Female

Ages

40 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

185 participants in 2 patient groups

Identyfication of prognostic factors in VO2max<17 ml/kg/min
Active Comparator group
Description:
Selected prognostic factors will be analyzed in patients with VO2max\<17 ml/kg/min
Treatment:
Diagnostic Test: Diagnostic tests
Identyfication of prognostic factors in VO2max>17 ml/kg/min
Sham Comparator group
Description:
Selected prognostic factors will be analyzed in patients with VO2max\>17 ml/kg/min
Treatment:
Diagnostic Test: Diagnostic tests

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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