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

Primary Purpose

Arterial Hypertension, Heart Failure

Status

Completed

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Diagnostic tests

About this trial

This is an interventional supportive care trial for Arterial Hypertension focused on measuring hypertension, exercise intolerance, troponin, body mass compartments

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Identyfication of prognostic factors in VO2max<17 ml/kg/min

Identyfication of prognostic factors in VO2max>17 ml/kg/min

Arm Description

Selected prognostic factors will be analyzed in patients with VO2max<17 ml/kg/min

Selected prognostic factors will be analyzed in patients with VO2max>17 ml/kg/min

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04802369

First Posted

March 12, 2021

Last Updated

March 25, 2021

Sponsor

Polish Mother Memorial Hospital Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04802369

Brief Title

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

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

January 28, 2020 (Actual)

Study Completion Date

February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Polish Mother Memorial Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arterial Hypertension, Heart Failure

Keywords

hypertension, exercise intolerance, troponin, body mass compartments

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

185 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Identyfication of prognostic factors in VO2max<17 ml/kg/min

Arm Type

Active Comparator

Arm Description

Selected prognostic factors will be analyzed in patients with VO2max<17 ml/kg/min

Arm Title

Identyfication of prognostic factors in VO2max>17 ml/kg/min

Arm Type

Sham Comparator

Arm Description

Selected prognostic factors will be analyzed in patients with VO2max>17 ml/kg/min

Intervention Type

Diagnostic Test

Intervention Name(s)

Diagnostic tests

Intervention Description

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.

Primary Outcome Measure Information:

Title

Prognosis in arterial hypertension

Description

Time Frame

One year after inclusion in the study

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Agata Bielecka-Dabrowa

Organizational Affiliation

Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI

Official's Role

Principal Investigator

Facility Information:

Facility Name

Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute

City

Łódź

ZIP/Postal Code

93-338

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

30234752

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. Erratum In: J Hypertens. 2019 Jan;37(1):226.

Results Reference

background

PubMed Identifier

36005402

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.

Results Reference

derived

PubMed Identifier

34442403

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.

Results Reference

derived

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

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