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NCT Number: NCT05839028

Mechanisms of LV Remodeling in Hypertensive Patients Working on a Rotational Expeditionary Basis in the Arctic

The main goal of our investigation is to study the mechanisms of formation of left ventricular remodeling in patients with hypertension, working on a rotational expedition basis in the Arctic.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tyumen Cardiology Research Center

Tyumen, Tyumen Oblast, 625026, Russia

About this study

Hypothesis: In patients with hypertension working in the conditions of the Arctic shift, the combination of climatic and geographical factors and rotational expeditionary method of labor contributes to the increase in the left ventricular remodeling processes and leads to the formation of heart failure with preserved ejection fraction.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient signed the informed consent

Exclusion criteria

  • Valvular pathology of the heart
  • Past cardiac or cerebral complications
  • Identified heart rhythm disturbances
  • Coronary heart disease
  • Patients with severe somatic pathology, whose prognostic survival rate does not exceed 1 year
  • The presence of a mental disorder of organic origin

Treatment and study plan

Primary outcomes

  1. Echocardiographic assessment of GLS (Global longitudinal strain), %

    Time frame: One year

    Echocardiographic assessment of global strain (%) at baseline and after one year of follow-up.

Secondary outcomes

  1. Concentration of Myeloperoxidase, ug/mL

    Time frame: One year

    Concentration of oxidative stress biomarker, myeloperoxidase, is assessed using Lab analyzer Stat Fax 4200 (USA).

  2. Concentration of oxidized low density lipoproteins, CU

    Time frame: One year

    Concentration of oxidative stress biomarker, oxidized low density lipoproteins, is assessed using Lab analyzer - Stat Fax 4200 (USA).

  3. Concentration of homocysteine, umol/L

    Time frame: One year

    Concentration of oxidative stress biomarker, homocysteine, is assessed using Lab analyzer - IMMULITE 2000 (Siemens Diagnostics, USA).

  4. Concentration of C-reactive protein, IU/L

    Time frame: One year

    Concentration of immune inflammation biomarker, C-reactive protein, is assessed using Lab analyzer - Stat Fax 4200 (USA).

  5. Concentration of tumor necrosis factor alpha, pg/ml

    Time frame: One year

    Concentration of immune inflammation biomarker, tumor necrosis factor alpha is assessed using Lab analyzer - Stat Fax 4200 (USA).

  6. Concentration of 1,6,8 interleukins, pg/mL

    Time frame: One year

    Concentration of immune inflammation biomarker, (1,6,8) interleukin, is assessed using Lab analyzer - Stat Fax 4200 (USA).

  7. Concentration of GDF-15/MIC-1 (Growth Differentiation Factor 15/Macrophage-inhibitory 1), pg/mL

    Time frame: One year

    Concentration fibrosis biomarker, GDF-15/MIC-1, is assessed using Lab analyzer - Stat Fax 4200 (USA).

  8. Concentration of PIIINP (N-terminal propeptide to procollagen III), ng/mL

    Time frame: One year

    Concentration of fibrosis biomarker, PIIINP, is assessed using Lab analyzer - Stat Fax 4200 (USA).

  9. Concentration of FGF-23 (Fibroblast growth factor 23), pmol/L

    Time frame: One year

    Concentration of fibrosis biomarker, FGF-23, is assessed using Lab analyzer - Stat Fax 4200 (USA).

  10. Concentration of plasma procollagen type 3, CU

    Time frame: One year

    Concentration of remodeling factor biomarker, plasma procollagen type 3, is assessed using Lab analyzer - Stat Fax 4200 (USA).

  11. Concentration of adrenaline, pg/mL

    Time frame: One year

    Concentration of catecholamine, adrenaline, is assessed using Lab analyzer - Stat Fax 4200 (USA).

  12. Concentration of noradrenaline, pg/mL

    Time frame: One year

    Concentration of catecholamine, noradrenaline, is assessed using Lab analyzer - Stat Fax 4200 (USA);

  13. Concentration of testosterone, nmol/L

    Time frame: One year

    Concentration of hormone, testosterone, is assessed using Lab analyzer - Stat Fax 4200 (USA).

  14. Concentration of progesterone, nmol/L

    Time frame: One year

    Concentration of hormone biomarker, progesterone, is assessed using Lab analyzer - Stat Fax 4200 (USA).

  15. Concentration of estradiol, pg/mL

    Time frame: One year

    Concentration of hormone, estradiol, is assessed using Lab analyzer - Stat Fax 4200 (USA).

  16. Concentration of cystatin-C, ng/mL

    Time frame: One year

    Concentration of chronic kidney disease biomarker, cystatin-C, is assessed by Lab analyzer - Stat Fax 4200 (USA).

  17. Concentration of NGAL (Neutrophilic gelatinase-associated lipocalin or neutrophilic lipocalin), ng/mL

    Time frame: One year

    Concentration of chronic kidney disease biomarker, NGAL, is assessed by Lab analyzer - Stat Fax 4200 (USA).

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Official study title

Mechanisms of Left Ventricular Remodeling in Hypertensive Patients Working on a Rotational Expeditionary Basis in the Conditions of the Arctic Region

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 3, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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