COPD (Chronic Obstructive Pulmonary Disease)HIPSTERNCT07375433
Heart Failure With Preserved Ejection Fraction in Patients With Сhronic Obstructive Pulmonary Disease: Clinical Course and Prognosis
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis), run by National Medical Research Center for Therapy and Preventive Medicine at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)
- What is being tested?
- Echocardiography, Spirometry and Body plethysmography
- How many people
- 200 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Generic russian population
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites, 2 recruiting
- Recruiting
Kazan State Medical University
Kazan'
Diana I Abdulganieva, MD, professor, +78432360922, diana.abdulganieva@kazangmu.ru
Elina R Kirillova, PhD, Associate Professor
- Recruiting
National Medical Research Center for Therapy and Preventive Medicine
Moscow
Olga N. Dzhioeva, MD, Associate Professor, +79166141821, odzhioeva@gnicpm.ru
Yriy S Timofeev, PhD
About this study
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.
Read the 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:
- 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.
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)
- Being tested
- Echocardiography, Spirometry, Body plethysmography, 6-Minute Walk Test (6MWT), laboratory biomarker analysis
- Keywords
- Heart failure, Heart failure with Preserved Ejection Fraction, Biomarkers, COPD, Prognosis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic 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
SpirometryDiagnostic 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 plethysmographyDiagnostic 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 analysisDiagnostic test
Routine and special laboratory tests
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Spirometry; Diagnostic Test: Body plethysmography; Diagnostic Test: 6-Minute Walk Test (6MWT); Diagnostic Test: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary composite endpoin
Primary composite endpoint: all-cause death, rehospitalizations, major adverse cardiovascular events (MACE)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Collaborators
- Kazan State Medical University
- Responsible party
- Sponsor
- Investigators
- Olga D Dzhioeva, MD, associate professor, Study director, National Medical Research Center for Therapy and Preventive MedicineDiana I Abdulganieva, MD, professor, Study director, Kazan State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375433
- Sponsor's protocol ID
- 06-08/25
- Acronym
- HIPSTER
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure With Preserved Ejection Fraction in Patients With Сhronic Obstructive Pulmonary Disease: Clinical Course and Prognosis
- ClinicalTrials.gov ID
- NCT07375433
- Acronym / sponsor ID
- HIPSTER / 06-08/25
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Collaborators
- Kazan State Medical University
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Сhronic Obstructive Pulmonary Disease | – | Diagnostic Test: Echocardiography, Diagnostic Test: Spirometry, Diagnostic Test: Body plethysmography, Diagnostic Test: 6-Minute Walk Test (6MWT), Diagnostic Test: laboratory biomarker analysisPatients hospitalized with a verified diagnosis of COPD. Patients with a confirmed diagnosis in accordance with instrumental and clinical criteria. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Generic russian population
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyTransthoracic 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 | Patients with Сhronic Obstructive Pulmonary Disease |
| SpirometrySpirometry 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 | Patients with Сhronic Obstructive Pulmonary Disease |
| Body plethysmographyBody 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 | Patients with Сhronic Obstructive Pulmonary Disease |
| 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 | Patients with Сhronic Obstructive Pulmonary Disease |
| laboratory biomarker analysisRoutine and special laboratory tests | Diagnostic test | Patients with Сhronic Obstructive Pulmonary Disease |
Primary outcome
Primary composite endpoin
Time frame: 1 year
Primary composite endpoint: all-cause death, rehospitalizations, major adverse cardiovascular events (MACE)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olga D Dzhioeva, MD, associate professor study director
National Medical Research Center for Therapy and Preventive Medicine
Diana I Abdulganieva, MD, professor study director
Kazan State Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis), run by National Medical Research Center for Therapy and Preventive Medicine at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yury S Timofeev, PhD (+79150104788, Timofeev_lab@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary composite endpoin (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.