Heart Failure With Preserved Ejection FractionNCT05839028
Mechanisms of LV Remodeling in Hypertensive Patients Working on a Rotational Expeditionary Basis in the Arctic
An observational study of Heart Failure With Preserved Ejection Fraction, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- How many people
- 550 participants
- Where
- 1 siteRussia
- Study dates
- 16 Oct 2022to 30 Oct 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- The patient signed the informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- hypertension, Arctic, rotational shift work, echocardiography
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic assessment of GLS (Global longitudinal strain), %
Echocardiographic assessment of global strain (%) at baseline and after one year of follow-up.
Measured: One year
Secondary outcomes (17)
Concentration of Myeloperoxidase, ug/mL
Concentration of oxidative stress biomarker, myeloperoxidase, is assessed using Lab analyzer Stat Fax 4200 (USA).
Measured: 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).
Measured: One year
Concentration of homocysteine, umol/L
Concentration of oxidative stress biomarker, homocysteine, is assessed using Lab analyzer - IMMULITE 2000 (Siemens Diagnostics, USA).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: One year
Concentration of adrenaline, pg/mL
Concentration of catecholamine, adrenaline, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Measured: One year
Concentration of noradrenaline, pg/mL
Concentration of catecholamine, noradrenaline, is assessed using Lab analyzer - Stat Fax 4200 (USA);
Measured: One year
Concentration of testosterone, nmol/L
Concentration of hormone, testosterone, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Measured: One year
Concentration of progesterone, nmol/L
Concentration of hormone biomarker, progesterone, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Measured: One year
Concentration of estradiol, pg/mL
Concentration of hormone, estradiol, is assessed using Lab analyzer - Stat Fax 4200 (USA).
Measured: 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).
Measured: 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).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start16 Oct 2022
- Primary completion28 Feb 2025
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liudmila Gapon, MD, PhD, Principal investigator, Tyumen Cardiology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839028
- Sponsor's protocol ID
- TCRC-183
- Status last verified
- Jun 2026
- First submitted
- 5 Apr 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Left Ventricular Remodeling in Hypertensive Patients Working on a Rotational Expeditionary Basis in the Conditions of the Arctic Region
- ClinicalTrials.gov ID
- NCT05839028
- Acronym / sponsor ID
- TCRC-183
- Keywords
- hypertension, Arctic, rotational shift work, echocardiography
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 16 Oct 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- The patient signed the informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Echocardiographic assessment of GLS (Global longitudinal strain), %
Time frame: One year
Echocardiographic assessment of global strain (%) at baseline and after one year of follow-up.
17 secondary outcomes
Concentration of Myeloperoxidase, ug/mL
Time frame: One year
Concentration of oxidized low density lipoproteins, CU
Time frame: One year
Concentration of homocysteine, umol/L
Time frame: One year
Concentration of C-reactive protein, IU/L
Time frame: One year
Concentration of tumor necrosis factor alpha, pg/ml
Time frame: One year
Concentration of 1,6,8 interleukins, pg/mL
Time frame: One year
Concentration of GDF-15/MIC-1 (Growth Differentiation Factor 15/Macrophage-inhibitory 1), pg/mL
Time frame: One year
Concentration of PIIINP (N-terminal propeptide to procollagen III), ng/mL
Time frame: One year
Concentration of FGF-23 (Fibroblast growth factor 23), pmol/L
Time frame: One year
Concentration of plasma procollagen type 3, CU
Time frame: One year
Concentration of adrenaline, pg/mL
Time frame: One year
Concentration of noradrenaline, pg/mL
Time frame: One year
Concentration of testosterone, nmol/L
Time frame: One year
Concentration of progesterone, nmol/L
Time frame: One year
Concentration of estradiol, pg/mL
Time frame: One year
Concentration of cystatin-C, ng/mL
Time frame: One year
Concentration of NGAL (Neutrophilic gelatinase-associated lipocalin or neutrophilic lipocalin), ng/mL
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liudmila Gapon, MD, PhD principal investigator
Tyumen Cardiology Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiographic assessment of GLS (Global longitudinal strain), % (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.