Hospital Register of Decompensated Heart Failure With Preserved Ejection Fraction

NCT06114498 | Active Not Recruiting DMC

• 1 other identifier: 04-05/23
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

Study Aim is creation of the Hospital Register of patients with heart failure with preserved ejection fraction (HFpEF) for a comprehensive assessment of the influence of gender characteristics, clinical and anamnestic factors, body composition, topical characteristics of congestion, instrumental data and markers of cellular inflammation and stress on immediate and long-term outcomes in patients with acute decompensated heart failure with preserved ejection fraction. During the study it is planned to assess gender, clinical and anamnestic indicators preceding hospitalization of patients in the hospital; characterize the features of comorbid status in the studied group of patient; study the features of drug therapy at the prehospital stage and during hospitalization in the study group of patient; assess adverse hospital outcomes and outcomes 6 months after hospital discharge and identify factors associated with them; assess body composition in patients with acute decompensated heart failure with preserved ejection fraction in obese patients upon admission to the hospital; characterize the severity and topical characteristics of congestion and compare with the phenotypes of acute decompensation of heart failure; asess adverse in-hospital outcomes and outcomes 6 months after hospital discharge and identify factors associated with them; conduct a clinical and instrumental examination of patients diagnosed with compensated and decompensated HFpEF, verified by echocardiography at rest, as well as in patients with HFpEF verified after an additional diastolic stress test with assessment of intracardiac hemodynamic; analyze the serum concentrations of biochemical markers associated with cellular stress in these groups of patients, as well as in the control group of apparently healthy people; conduct an analysis of associations of biomarker levels with clinical characteristics of patients, the presence of comorbid diseases, including obesity, as well as with data from instrumental examination methods; assess the diagnostic capabilities of HFpEF, defined by various criteria, based on the concentration of the new biomarkers The results obtained will allow us to evaluate the characteristics of the course and outcomes of the disease in Moscow patients, depending on the phenotype of acute decompensation of HFpEF, hospitalized in the hospital during the study period. It is expected to identify phenotypes of acute decompensation of HFpEF that affect the duration of hospitalization and the development of adverse outcomes in the hospital and long-term period of the disease.

Conditions

Obesity, Mild; Decompensated Heart Failure; Heart Failure With Preserved Ejection Fraction

Keywords

Hearth failure; Decompensated Heart Failure; Heart Failure with Preserved Ejection Fraction; HFpEF; Heat shock protein; Obesity

Outcome Measures

Primary Outcomes (1)

• Amount of secondary hospitalisations

  Hospitalisations with decompensation of HFpEF

  6 months

Secondary Outcomes (4)

• Amount of hospitalisations with acute coronary syndrome

  6 months

• Amount of hospitalisations with stroke

  6 months

• Amount of hospitalisations with pulmonary embolism

  6 months

• Amount of other cardiovascular events

  6 months

Study Arms (2)

Patient with HFpEF with decompensation

120 patients hospitalized with a clinical picture of acute decompensation of heart failure (shortness of breath, orthopnea, clinical signs of "cardiac asthma" and/or "pulmonary edema") in the city clinical hospital named after. V.V. Veresaeva, Moscow. Patients with a confirmed diagnosis in accordance with instrumental and/or laboratory criteria

Diagnostic Test: Echocardiography; Diagnostic Test: Bioimpedance; Diagnostic Test: Immunoassay; Diagnostic Test: Routine biochemistry

Control group

40 particularly healthy people without heart failure and acute cardiovascular diseases

Diagnostic Test: Bioimpedance; Diagnostic Test: Immunoassay; Diagnostic Test: Routine biochemistry

Interventions

Routine biochemistry DIAGNOSTIC_TEST

Measuring of routine biochemical parameters (glucose, total protein, creatinine, urea, uric acid, total bilirubin, direct bilirubin, total cholesterol, triglycerides, low and high density lipoprotein cholesterol, Lactate dehydrogenase, creatine phosphokinase, aspartate aminotransferase, alanine aminotransferase, sodium, potassium and special (C-reactive protein, N-terminal pro b-type natriuretic peptide)

Control group; Patient with HFpEF with decompensation

Bioimpedance DIAGNOSTIC_TEST

Bioelectrical impedance analysis research

Control group; Patient with HFpEF with decompensation

Immunoassay DIAGNOSTIC_TEST

Enzyme immunoassay of heat shock proteins in blood serum

Also known as: ELISA

Control group; Patient with HFpEF with decompensation

Echocardiography DIAGNOSTIC_TEST

Transthoracic echocardiography at rest: with determination of epicardial fat tissue thickness, intensity of mitral regurgitation.

Patient with HFpEF with decompensation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Generic Moscow population

You may qualify if:

• All patients hospitalized with a clinical picture of acute decompensation of heart failure (shortness of breath, orthopnea, clinical signs of "cardiac asthma" and/or "pulmonary edema") in the city clinical hospital named after. V.V. Veresaeva, Moscow. Patients with a confirmed diagnosis in accordance with instrumental (EchoCG) and/or laboratory criteria.

You may not qualify if:

• Refusal to sign informed consent to participate in a clinical trial and to process personal data.

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead
• Moscow State Clinical Hospital named after V.V. Veresaev: collaborator

Study Sites (2)

Moscow State Clinical Hospital named after V.V. Veresaev

Moscow, Russia

Location

National Medical Research Center for Therapy and Preventive Medicine

Moscow, Russia

Location

Related Publications (5)

• Timofeev YS, Kiselev AR, Dzhioeva ON, Drapkina OM. Heat Shock Proteins (HSPs) and Cardiovascular Complications of Obesity: Searching for Potential Biomarkers. Curr Issues Mol Biol. 2023 Nov 23;45(12):9378-9389. doi: 10.3390/cimb45120588.

  PMID: 38132434 BACKGROUND

• Rogozhkina E.A., Vedenikin T.Yu., Timofeev Yu.S., Ivanova A.A., Afaunova A.R., Dzhioeva O.N., Drapkina O.M. Comparative assessment of venous congestion severity and hospitalization outcomes in patients with acute decompensated heart failure with preserved ejection fraction. Russian Journal of Cardiology. 2024;29(7):5977. (In Russ.) https://doi.org/10.15829/1560-4071-2024-5977. EDN: RGBFNE

  RESULT

• Timofeev Yu.S., Afaunova A.R., Ivanova A.A., Vedenikin T.Yu., Dzhioeva O.N., Metelskaya V.A., Pokrovskaya M.S., Drapkina O.M. Interaction of serum heat shock proteins' levels with the severity of venous congestion in patients with acute decompensated heart failure with preserved ejection fraction. Cardiovascular Therapy and Prevention. 2024;23(6):4037. (In Russ.) https://doi.org/10.15829/1728-8800-2024-4037. EDN: HXKJTD

  RESULT

• Timofeev Yu.S., Vedenikin T.Yu., Afaunova A.R., Zamyatin R.A., Metelskaya V.A., Dzhioeva O.N., Ivanova A.A., Neshkova E.A., Pokrovskaya M.S., Drapkina O.M. Heat shock proteins in the assessment of the course and prognosis of heart failure with preserved ejection fraction. Russian Journal of Cardiology. 2025;30(4):6317. (In Russ.) https://doi.org/10.15829/1560-4071-2025-6317. EDN: YHFXWZ

  RESULT

• Timofeev Yu.S., Metelskaya V.A., Ivanova A.A., Dubovskaya N.I., Rogozhkina E.A., Vedenikin T.Yu., Zamyatin R.A., Borisova A.L., Dzhioeva O.N., Drapkina O.M. Serum biochemical profile in patients with decompensated heart failure with preserved ejection fraction depending on obesity. Cardiovascular Therapy and Prevention. 2025;24(7):4453. (In Russ.) https://doi.org/10.15829/1728-8800-2025-4453. EDN: TEWGYU

  RESULT

MeSH Terms

Conditions

Obesity; Lymphoma, Follicular

Interventions

Echocardiography; Fluorescence Polarization Immunoassay

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Fluoroimmunoassay; Fluorescent Antibody Technique; Immunohistochemistry; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Histological Techniques; Fluorescence Polarization; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Immunoassay; Immunologic Techniques

Study Officials

• Yury Timfeev, PhD

  National Medical Research Center for Therapy and Preventive Medicine

  PRINCIPAL INVESTIGATOR

• Olga Dzhioeva, MD

  National Medical Research Center for Therapy and Preventive Medicine

  STUDY DIRECTOR

• Timofei Vedenikin

  Moscow State Clinical Hospital named after V.V. Veresaev

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2023
• First Posted: November 2, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

RU (2)