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

Active, not recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT05839028
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

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 Timeline

• Study Start: 2022-10-16
• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-19
• Study First Posted: 2023-05-03
• Primary Completion: 2025-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Echocardiographic assessment of GLS (Global longitudinal strain), %	One year	Echocardiographic assessment of global strain (%) at baseline and after one year of follow-up.

Secondary Outcome Measures

Name	Time	Method
Concentration of oxidized low density lipoproteins, CU	One year	Concentration of oxidative stress biomarker, oxidized low density lipoproteins, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Concentration of homocysteine, umol/L	One year	Concentration of oxidative stress biomarker, homocysteine, is assessed using Lab analyzer - IMMULITE 2000 (Siemens Diagnostics, USA).
Concentration of C-reactive protein, IU/L	One year	Concentration of immune inflammation biomarker, C-reactive protein, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Concentration of 1,6,8 interleukins, pg/mL	One year	Concentration of immune inflammation biomarker, (1,6,8) interleukin, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Concentration of GDF-15/MIC-1 (Growth Differentiation Factor 15/Macrophage-inhibitory 1), pg/mL	One year	Concentration fibrosis biomarker, GDF-15/MIC-1, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Concentration of testosterone, nmol/L	One year	Concentration of hormone, testosterone, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Concentration of Myeloperoxidase, ug/mL	One year	Concentration of oxidative stress biomarker, myeloperoxidase, is assessed using Lab analyzer Stat Fax 4200 (USA).
Concentration of noradrenaline, pg/mL	One year	Concentration of catecholamine, noradrenaline, is assessed using Lab analyzer - Stat Fax 4200 (USA);
Concentration of FGF-23 (Fibroblast growth factor 23), pmol/L	One year	Concentration of fibrosis biomarker, FGF-23, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Concentration of tumor necrosis factor alpha, pg/ml	One year	Concentration of immune inflammation biomarker, tumor necrosis factor alpha is assessed using Lab analyzer - Stat Fax 4200 (USA).
Concentration of PIIINP (N-terminal propeptide to procollagen III), ng/mL	One year	Concentration of fibrosis biomarker, PIIINP, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Concentration of plasma procollagen type 3, CU	One year	Concentration of remodeling factor biomarker, plasma procollagen type 3, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Concentration of progesterone, nmol/L	One year	Concentration of hormone biomarker, progesterone, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Concentration of adrenaline, pg/mL	One year	Concentration of catecholamine, adrenaline, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Concentration of estradiol, pg/mL	One year	Concentration of hormone, estradiol, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Concentration of cystatin-C, ng/mL	One year	Concentration of chronic kidney disease biomarker, cystatin-C, is assessed by Lab analyzer - Stat Fax 4200 (USA).
Concentration of NGAL (Neutrophilic gelatinase-associated lipocalin or neutrophilic lipocalin), ng/mL	One year	Concentration of chronic kidney disease biomarker, NGAL, is assessed by Lab analyzer - Stat Fax 4200 (USA).

Trial Locations

Locations (1)

Tyumen Cardiology Research Center; 🇷🇺 Tyumen, Russian Federation