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Clinical Trials/NCT05839028
NCT05839028
Active, not recruiting
Not Applicable

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

Tomsk National Research Medical Center of the Russian Academy of Sciences1 site in 1 country550 target enrollmentOctober 16, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure With Preserved Ejection Fraction
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
Enrollment
550
Locations
1
Primary Endpoint
Echocardiographic assessment of GLS (Global longitudinal strain), %
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 16, 2022
End Date
October 30, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Concentration of oxidized low density lipoproteins, CU(One year)
  • Concentration of homocysteine, umol/L(One year)
  • Concentration of C-reactive protein, IU/L(One year)
  • Concentration of 1,6,8 interleukins, pg/mL(One year)
  • Concentration of GDF-15/MIC-1 (Growth Differentiation Factor 15/Macrophage-inhibitory 1), pg/mL(One year)
  • Concentration of testosterone, nmol/L(One year)
  • Concentration of Myeloperoxidase, ug/mL(One year)
  • Concentration of noradrenaline, pg/mL(One year)
  • Concentration of FGF-23 (Fibroblast growth factor 23), pmol/L(One year)
  • Concentration of tumor necrosis factor alpha, pg/ml(One year)
  • Concentration of PIIINP (N-terminal propeptide to procollagen III), ng/mL(One year)
  • Concentration of plasma procollagen type 3, CU(One year)
  • Concentration of progesterone, nmol/L(One year)
  • Concentration of adrenaline, pg/mL(One year)
  • Concentration of estradiol, pg/mL(One year)
  • Concentration of cystatin-C, ng/mL(One year)
  • Concentration of NGAL (Neutrophilic gelatinase-associated lipocalin or neutrophilic lipocalin), ng/mL(One year)

Study Sites (1)

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