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

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05839028

Collaborator

(none)

550

Enrollment

Location

25.5

Anticipated Duration (Months)

21.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

550 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 16, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

Myeloperoxidase, ug/ml [One year]
Biomarker of oxidative stress; Lab analyzer - Stat Fax 4200 (USA);
Oxidized low density lipoproteins [One year]
Biomarker of oxidative stress; Lab analyzer - Stat Fax 4200 (USA)
Homocysteine, umol/l [One year]
Biomarker of oxidative stress; Lab analyzer - IMMULITE 2000 (Siemens Diagnostics, USA);
C-reactive protein, IU/L [One year]
Biomarker of immune inflammation; Lab analyzer - Stat Fax 4200 (USA);
Tumor necrosis factor alpha, pg/ml [One year]
Biomarker of immune inflammation; Lab analyzer - Stat Fax 4200 (USA);
1,6,8 interleukins, pg/ml [One year]
Biomarker of immune inflammation; Lab analyzer - Stat Fax 4200 (USA);
GDF-15/MIC-1 (Growth Differentiation Factor 15/Macrophage-inhibitory 1), pg/ml [One year]
Biomarker of fibrosis; Lab analyzer - Stat Fax 4200 (USA);
PIIINP (N-terminal propeptide to procollagen III), ng/ml [One year]
Biomarker of fibrosis; Lab analyzer - Stat Fax 4200 (USA);
FGF-23 (Fibroblast growth factor 23), pmol/l [One year]
Biomarker of fibrosis; Lab analyzer - Stat Fax 4200 (USA);
Plasma procollagen type 3 [One year]
Biomarker of remodeling factors; Lab analyzer - Stat Fax 4200 (USA);
Adrenaline, pg/ml [One year]
Catecholamine; Lab analyzer - Stat Fax 4200 (USA);
Noradrenaline, pg/ml [One year]
Catecholamine; Lab analyzer - Stat Fax 4200 (USA);
Testosterone, nmol/l [One year]
Hormone; Lab analyzer - Stat Fax 4200 (USA);
Progesterone, nmol/l [One year]
Biomarker of hormones; Lab analyzer - Stat Fax 4200 (USA);
Estradiol, pg/ml [One year]
Hormone; Lab analyzer - Stat Fax 4200 (USA);
Cystatin-C, ng/ml [One year]
Biomarker of chronic kidney disease; Lab analyzer - Stat Fax 4200 (USA);
NGAL (Neutrophilic gelatinase-associated lipocalin or neutrophilic lipocalin), ng/ml [One year]
Biomarker of chronic kidney disease; Lab analyzer - Stat Fax 4200 (USA);

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tyumen Cardiology Research Center	Tyumen		Russian Federation	625026

Sponsors and Collaborators

Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

Principal Investigator: Liudmila Gapon, MD, PhD, Tyumen Cardiology Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tomsk National Research Medical Center of the Russian Academy of Sciences

ClinicalTrials.gov Identifier:

NCT05839028

Other Study ID Numbers:

TomskNRMC HD

First Posted:

May 3, 2023

Last Update Posted:

May 3, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tomsk National Research Medical Center of the Russian Academy of Sciences

hypertension

Arctic

rotational shift work

echocardiography

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of May 3, 2023