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

NCT04802369 | Completed

• 1 other identifier: PMMHRI-BCO.71/2020
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Hypertension; Heart Failure

Keywords

hypertension; exercise intolerance; troponin; body mass compartments

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Diagnostic Test: Diagnostic tests

Interventions

Diagnostic tests DIAGNOSTIC_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.

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

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Polish Mother Memorial Hospital Research Institute: lead

Study Sites (1)

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

Lodz, 93-338, Poland

Location

Related Publications (3)

• 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.

  PMID: 30234752 BACKGROUND

• 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.

  PMID: 36005402 DERIVED

• 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.

  PMID: 34442403 DERIVED

MeSH Terms

Conditions

Hypertension; Heart Failure

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Agata Bielecka-Dabrowa

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: February 1, 2019
• Primary Completion: January 28, 2020
• Study Completion: February 28, 2021
• Last Updated: April 3, 2024

Record last verified: 2021-02

Locations

PL (1)