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

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 Overview

• Status: Recruiting
• Conditions: COPD (Chronic Obstructive Pulmonary Disease); Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)
• Intervention / Treatment: Diagnostic test: Echocardiography; Diagnostic test: Spirometry; Diagnostic test: Body plethysmography; Diagnostic test: 6-Minute Walk Test (6MWT); Diagnostic test: laboratory biomarker analysis

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Yury S Timofeev, PhD; Phone Number: +79150104788; Email: Timofeev_lab@mail.ru

Study Locations

• Russia
  • Kazan', Russia
    • Recruiting
    • Kazan State Medical University
    • Contact: Diana I Abdulganieva, MD, professor; Phone Number: +78432360922; Email: diana.abdulganieva@kazangmu.ru
    • Sub-Investigator: Elina R Kirillova, PhD, Associate Professor
    • Sub-Investigator: Nailya G Shamsutdinova, PhD, Associate Professor
    • Principal Investigator: Diana I Abdulganieva, MD, professor
  • Moscow, Russia
    • Recruiting
    • National Medical Research Center for Therapy and Preventive Medicine
    • Contact: Olga N. Dzhioeva, MD, Associate Professor; Phone Number: +79166141821; Email: odzhioeva@gnicpm.ru
    • Sub-Investigator: Yriy S Timofeev, PhD
    • Sub-Investigator: Elizaveta A. Rogozhkina, PhD
    • Principal Investigator: Olga N Dzhioeva, PhD, Associate Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Generic russian population

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary composite endpoin	Primary composite endpoint: all-cause death, rehospitalizations, major adverse cardiovascular events (MACE)	1 year

Collaborators and Investigators

• Sponsor: National Medical Research Center for Therapy and Preventive Medicine
• Collaborators: Kazan State Medical University
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Prognosis; COPD; Heart failure; Biomarkers; Heart failure with Preserved Ejection Fraction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Heart Failure; Pulmonary Disease, Chronic Obstructive; Disease; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Respiratory System; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Respiratory Function Tests; Cardiac Imaging Techniques; Ultrasonography; Exercise Test; Plethysmography; Spirometry; Echocardiography; Walk Test; Plethysmography, Whole Body
• Other Study ID Numbers: 06-08/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No