Heart Failure With Preserved Ejection Fraction in Patients With Сhronic Obstructive Pulmonary Disease: Clinical Course and Prognosis

NCT07375433 | Recruiting DMC

• 1 other identifier: 06-08/25
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)

Keywords

Heart failure; Heart failure with Preserved Ejection Fraction; Biomarkers; COPD; Prognosis

Outcome Measures

Primary Outcomes (1)

• Primary composite endpoin

  Primary composite endpoint: all-cause death, rehospitalizations, major adverse cardiovascular events (MACE)

  1 year

Study Arms (1)

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.

Diagnostic Test: Echocardiography; Diagnostic Test: Spirometry; Diagnostic Test: Body plethysmography; Diagnostic Test: 6-Minute Walk Test (6MWT); Diagnostic Test: laboratory biomarker analysis

Interventions

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

Patients with Сhronic Obstructive Pulmonary Disease

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.

Patients with Сhronic Obstructive Pulmonary Disease

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

Patients with Сhronic Obstructive Pulmonary Disease

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

Patients with Сhronic Obstructive Pulmonary Disease

laboratory biomarker analysis DIAGNOSTIC_TEST

Routine and special laboratory tests

Patients with Сhronic Obstructive Pulmonary Disease

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Generic russian population

You may qualify if:

• Verified diagnosis of COPD;
• Patients hospitalized with COPD;
• Citizenship of the Russian Federation;
• Patients aged 50 to 70 years;
• Patient consent to participate in the study.

You may not qualify if:

• Lack of Russian Federaion citizenship;
• Patient's refusal to participate in the study;
• Any chronic diseases, other than COPD, that affect the prognosis, in the acute and/or decompensated stage;
• Mental disorders.

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead
• Kazan State Medical University: collaborator

Study Sites (2)

Kazan State Medical University

Kazan', Russia

RECRUITING

National Medical Research Center for Therapy and Preventive Medicine

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Disease; Heart Failure

Interventions

Echocardiography; Spirometry; Plethysmography, Whole Body; Walk Test

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Plethysmography; Exercise Test

Study Officials

• 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

Central Study Contacts

Yury S Timofeev, PhD

CONTACT

+79150104788; Timofeev_lab@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-01

Locations

RU (2)