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NCT Number: NCT07375433

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

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.

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Key information

About this study

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:

  • 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.
  • Identify the patients with previously undiagnosed HFpEF among patients with COPD, and evaluate the frequency of cardiorespiratory comorbidity.
  • Examine the general clinical and biochemical blood test parameters in the study groups (as part of a routine in-patient examination).
  • 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).
  • Compare spirometry and body plethysmography parameters in the groups depending on the presence of HFpEF criteria.
  • Compare the functional status (Six-Minute Walk Test, 6MWT) in the study groups.
  • Evaluate patient's vital status after 12 months, information about hospitalizations and their reasons.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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

Primary outcomes

  1. Primary composite endpoin

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yury S Timofeev, PhD

CONTACT

[email protected]

+79150104788

Sponsors and collaborators

Lead sponsor

National Medical Research Center for Therapy and Preventive Medicine

Other Gov

Collaborators

  • Kazan State Medical University

Registry information

Acronym: HIPSTER

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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