NCT07375433

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: National Medical Research Center for Therapy and Preventive Medicine · Other Government
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Echocardiography	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_TEST	Spirometry	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_TEST	Body 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_TEST	6-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_TEST	laboratory biomarker analysis	Routine and special laboratory tests

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-01-29
• Last updated: 2026-02-10

Locations

2 sites across 1 country: Russia