Clinical trial NCT05839028: Mechanisms of LV Remodeling in Hypertensive Patients Working on a Rotational Expeditionary Basis in the Arctic
Official title: Mechanisms of Left Ventricular Remodeling in Hypertensive Patients Working on a Rotational Expeditionary Basis in the Conditions of the Arctic Region
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: hypertension
Arctic
rotational shift work
echocardiography
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Зatients with hypertension of stages 1 and 2 and practically healthy individuals living in a temperate climate zone and carrying out an Arctic watch. Hypertension in the Arctic is characterized by faster target organ damage and worse prognosis.

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.

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

Primary outcomes:
measure: Echocardiographic assessment of GLS (Global longitudinal strain), %
timeFrame: One year
Secondary outcomes:
measure: Concentration of Myeloperoxidase, ug/mL
timeFrame: One year
measure: Concentration of oxidized low density lipoproteins, CU
timeFrame: One year
measure: Concentration of homocysteine, umol/L
timeFrame: One year
measure: Concentration of C-reactive protein, IU/L
timeFrame: One year
measure: Concentration of tumor necrosis factor alpha, pg/ml
timeFrame: One year
measure: Concentration of 1,6,8 interleukins, pg/mL
timeFrame: One year
measure: Concentration of GDF-15/MIC-1 (Growth Differentiation Factor 15/Macrophage-inhibitory 1), pg/mL
timeFrame: One year
measure: Concentration of PIIINP (N-terminal propeptide to procollagen III), ng/mL
timeFrame: One year
measure: Concentration of FGF-23 (Fibroblast growth factor 23), pmol/L
timeFrame: One year
measure: Concentration of plasma procollagen type 3, CU
timeFrame: One year
measure: Concentration of adrenaline, pg/mL
timeFrame: One year
measure: Concentration of noradrenaline, pg/mL
timeFrame: One year
measure: Concentration of testosterone, nmol/L
timeFrame: One year
measure: Concentration of progesterone, nmol/L
timeFrame: One year
measure: Concentration of estradiol, pg/mL
timeFrame: One year
measure: Concentration of cystatin-C, ng/mL
timeFrame: One year
measure: Concentration of NGAL (Neutrophilic gelatinase-associated lipocalin or neutrophilic lipocalin), ng/mL
timeFrame: One year
Other outcomes:
Locations:
city: Tyumen
country: Russian Federation
facility: Tyumen Cardiology Research Center
Study officials:
affiliation: Tyumen Cardiology Research Center
name: Liudmila Gapon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: