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| Name | Class |
|---|---|
| Kazan State Medical University | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Сhronic Obstructive Pulmonary Disease | Patients hospitalized with a verified diagnosis of COPD. Patients with a confirmed diagnosis in accordance with instrumental and clinical criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Primary composite endpoin | Primary composite endpoint: all-cause death, rehospitalizations, major adverse cardiovascular events (MACE) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Generic russian population
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yury S Timofeev, PhD | Contact | +79150104788 | Timofeev_lab@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Olga D Dzhioeva, MD, associate professor | National Medical Research Center for Therapy and Preventive Medicine | Study Director |
| Diana I Abdulganieva, MD, professor | Kazan State Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kazan State Medical University | Recruiting | Kazan' | Russia |
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|
| Spirometry | Diagnostic Test | 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. |
|
| Body plethysmography | Diagnostic Test | 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 |
|
| 6-Minute Walk Test (6MWT) | Diagnostic Test | 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 |
|
| laboratory biomarker analysis | Diagnostic Test | Routine and special laboratory tests |
|
| National Medical Research Center for Therapy and Preventive Medicine | Recruiting | Moscow | Russia |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004194 | Disease |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D013147 | Spirometry |
| D010993 | Plethysmography, Whole Body |
| D000070857 | Walk Test |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D010991 | Plethysmography |
| D005080 | Exercise Test |
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