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

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05839028
• Other study ID #: TomskNRMC HD
• Status: Active, not recruiting
• Start date: October 16, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2023
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 550
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Locations

Country	Name	City	State
Russian Federation	Tyumen Cardiology Research Center	Tyumen

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiographic assessment of GLS (Global longitudinal strain), %	Echocardiographic assessment of global strain (%) at baseline and after one year of follow-up.	One year
Secondary	Concentration of Myeloperoxidase, ug/mL	Concentration of oxidative stress biomarker, myeloperoxidase, is assessed using Lab analyzer Stat Fax 4200 (USA).	One year
Secondary	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
Secondary	Concentration of homocysteine, umol/L	Concentration of oxidative stress biomarker, homocysteine, is assessed using Lab analyzer - IMMULITE 2000 (Siemens Diagnostics, USA).	One year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Concentration of adrenaline, pg/mL	Concentration of catecholamine, adrenaline, is assessed using Lab analyzer - Stat Fax 4200 (USA).	One year
Secondary	Concentration of noradrenaline, pg/mL	Concentration of catecholamine, noradrenaline, is assessed using Lab analyzer - Stat Fax 4200 (USA);	One year
Secondary	Concentration of testosterone, nmol/L	Concentration of hormone, testosterone, is assessed using Lab analyzer - Stat Fax 4200 (USA).	One year
Secondary	Concentration of progesterone, nmol/L	Concentration of hormone biomarker, progesterone, is assessed using Lab analyzer - Stat Fax 4200 (USA).	One year
Secondary	Concentration of estradiol, pg/mL	Concentration of hormone, estradiol, is assessed using Lab analyzer - Stat Fax 4200 (USA).	One year
Secondary	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
Secondary	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