NCT05839028Active, not recruitingNot 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 Sciences2 sites in 2 countries550 target enrollmentStarted: October 16, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 550
- Locations
- 2
- Primary Endpoint
- Echocardiographic assessment of GLS (Global longitudinal strain), %
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Investigators
Study Sites (2)
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