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

NCT05839028 | Active Not Recruiting

• 1 other identifier: TCRC-183
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

hypertension; Arctic; rotational shift work; echocardiography

Outcome Measures

Primary Outcomes (1)

• Echocardiographic assessment of GLS (Global longitudinal strain), %

  Echocardiographic assessment of global strain (%) at baseline and after one year of follow-up.

  One year

Secondary Outcomes (17)

• Concentration of Myeloperoxidase, ug/mL

  One year

• 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 tumor necrosis factor alpha, pg/ml

  One year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• The patient signed the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Tyumen Cardiology Research Center

Tyumen, Tyumen Oblast, 625026, Russia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biomarkers of inflammation and biomarkers that allow to detect heart failure with preserved ejection fraction at an early stage

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Liudmila Gapon, MD, PhD

  Tyumen Cardiology Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 3, 2023
• Study Start: October 16, 2022
• Primary Completion: February 28, 2025
• Study Completion (Estimated): October 30, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

Locations

RU (1)