COPD (Chronic Obstructive Pulmonary Disease), Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)
Conditions
Keywords
Heart failure, Heart failure with Preserved Ejection Fraction, Biomarkers, COPD, Prognosis
Brief summary
Study aim is comparison of heart failire with preserved ejection fraction (HFpEF) detection rate in patients with Сhronic Obstructive Pulmonary Disease (COPD) and the clinical course and prognosis in patients with COPD depending on HFpEF presence.
Detailed description
Study aim of Investigation "Heart Failure with Preserved Ejection Fraction in Patients with Сhronic Obstructive Pulmonary Disease: Clinical Course and Prognosis" (HIPSTER) is comparison of heart failire with preserved ejection fraction (HFpEF) detection rate in patients with Сhronic Obstructive Pulmonary Disease (COPD) and the clinical course and prognosis in patients with COPD depending on HFpEF presence. It is assumed that newly diagnosed HFpEF will occur in at least 6% (COPD PRIORITY data) of cases, and, the presence of HFpEF will negatively affect both the manifestations of the disease and the outcomes and prognosis During the study it is planned to: 1. Perform a retrospective analysis of patient records, determine the frequency of intracardiac hemodynamic disorders, corresponding with the criteria for HFpEF and compare them with the diagnosis in clinical records. 2. Identify the patients with previously undiagnosed HFpEF among patients with COPD, and evaluate the frequency of cardiorespiratory comorbidity. 3. Examine the general clinical and biochemical blood test parameters in the study groups (as part of a routine in-patient examination). 4. Evaluate echocardiography parameters in the study groups (as part of a routine protocol + epicardial adipose tissue thickness (EAT), E/e', interventricular septum thickness, left ventricular posterior wall thickness, and end-diastolic dimension (EDD). 5. Compare spirometry and body plethysmography parameters in the groups depending on the presence of HFpEF criteria. 6. Compare the functional status (Six-Minute Walk Test, 6MWT) in the study groups. 7. Evaluate patient's vital status after 12 months, information about hospitalizations and their reasons.
Interventions
DIAGNOSTIC_TESTEchocardiography
Transthoracic echocardiography at rest: with determination of epicardial fat tissue thickness, epicardial adipose tissue thickness (EAT), E/e', interventricular septum thickness, left ventricular posterior wall thickness, and end-diastolic dimension
DIAGNOSTIC_TESTSpirometry
Spirometry is the most common of the pulmonary function tests, which measures the lung capacity and airway patency (volume and speed of air) during quiet and forced breathing.
DIAGNOSTIC_TESTBody plethysmography
Body plethysmography is a non-invasive lung function test performed in a sealed booth (body box) that measures total lung volume, functional residual capacity, and airway resistance by using Boyle's Law to track pressure and volume changes as a patient breathes, providing crucial data for diagnosing conditions like COPD and asthma, and differentiating them from other lung disorders
DIAGNOSTIC_TEST6-Minute Walk Test (6MWT)
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity
DIAGNOSTIC_TESTlaboratory biomarker analysis
Routine and special laboratory tests
Sponsors
National Medical Research Center for Therapy and Preventive Medicine
Kazan State Medical University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Verified diagnosis of COPD; 2. Patients hospitalized with COPD; 3. Citizenship of the Russian Federation; 4. Patients aged 50 to 70 years; 5. Patient consent to participate in the study.
Exclusion criteria
1. Lack of Russian Federaion citizenship; 2. Patient's refusal to participate in the study; 3. Any chronic diseases, other than COPD, that affect the prognosis, in the acute and/or decompensated stage; 4. Mental disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary composite endpoin | 1 year | Primary composite endpoint: all-cause death, rehospitalizations, major adverse cardiovascular events (MACE) |
Countries
Russia
Contacts
CONTACTYury S Timofeev, PhD
STUDY_DIRECTOROlga D Dzhioeva, MD, associate professor
National Medical Research Center for Therapy and Preventive Medicine
STUDY_DIRECTORDiana I Abdulganieva, MD, professor
Kazan State Medical University
Outcome results
None listed