Arterial HypertensionNCT04802369
Factors and Prognostic Significance of Impaired Exercise Tolerance in Women Over 40 With Arterial Hypertension
A study testing Diagnostic tests in people with Arterial Hypertension and Heart Failure, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 40 to 99 years, women only
- Conditions the study is for
- Arterial Hypertension, Heart Failure
- What is being tested?
- Diagnostic tests
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2019to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
Poland1 site
Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute
Lodz, 93-338
About this study
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.
Read the 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.
- Conditions
- Arterial Hypertension, Heart Failure
- Being tested
- Diagnostic tests
- Keywords
- hypertension, exercise intolerance, troponin, body mass compartments
- Medical subject headings
- Hypertension, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testsDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Identyfication of prognostic factors in VO2max<17 ml/kg/min | Active comparator | Selected prognostic factors will be analyzed in patients with VO2max<17 ml/kg/min Receives: Diagnostic Test: Diagnostic tests |
| Identyfication of prognostic factors in VO2max>17 ml/kg/min | Sham comparator | Selected prognostic factors will be analyzed in patients with VO2max>17 ml/kg/min Receives: Diagnostic Test: Diagnostic tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Feb 2019
- Primary completion28 Jan 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polish Mother Memorial Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agata Bielecka-Dabrowa, Principal investigator, Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802369
- Sponsor's protocol ID
- PMMHRI-BCO.71/2020
- Status last verified
- Feb 2021
- First submitted
- 12 Mar 2021
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30234752Bielecka-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.
PubMed 36005402Bielecka-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.
PubMed 34442403
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors and Prognostic Significance of Impaired Exercise Tolerance in Women Over 40 With Arterial Hypertension
- ClinicalTrials.gov ID
- NCT04802369
- Acronym / sponsor ID
- PMMHRI-BCO.71/2020
- Conditions
- Arterial Hypertension, Heart Failure
- Keywords
- hypertension, exercise intolerance, troponin, body mass compartments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Polish Mother Memorial Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Identyfication of prognostic factors in VO2max<17 ml/kg/min | Active comparator | Diagnostic Test: Diagnostic testsSelected prognostic factors will be analyzed in patients with VO2max<17 ml/kg/min |
| Identyfication of prognostic factors in VO2max>17 ml/kg/min | Sham comparator | Diagnostic Test: Diagnostic testsSelected prognostic factors will be analyzed in patients with VO2max>17 ml/kg/min |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic testsSelected 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. | Diagnostic test | Identyfication of prognostic factors in VO2max<17 ml/kg/min, Identyfication of prognostic factors in VO2max>17 ml/kg/min |
Primary outcome
Prognosis in arterial hypertension
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Background: PubMed 30234752Williams 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.
- Derived from this study: PubMed 36005402Bielecka-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.
- Derived from this study: PubMed 34442403Bielecka-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agata Bielecka-Dabrowa principal investigator
Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic tests in people with Arterial Hypertension and Heart Failure, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognosis in arterial hypertension (time frame: One year after inclusion in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04802369, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.