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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure With Preserved Ejection Fraction

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 Type: Observational
• Enrollment (Estimated): 550

Contacts and Locations

Study Locations

• Russian Federation
  • Tyumen, Russian Federation, 625026
    • Tyumen Cardiology Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with hypertension of stages 1 and 2; Individuals with stage 1 and 2 hypertension living in a temperate climate zone and doing rotational shiftwork in the Arctic.
Healthy volunteers; Virtually healthy individuals living in a temperate climate zone and and doing rotational shiftwork in the Arctic.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Investigators: Principal Investigator: Liudmila Gapon, MD, PhD, Tyumen Cardiology Research Center

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2022
• Primary Completion (Actual): February 28, 2025
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: hypertension; echocardiography; Arctic; rotational shift work
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: TomskNRMC HD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
• IPD Sharing Time Frame: Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data warehouse but without investigator support other than deposited metadata.
• IPD Sharing Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No