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Recruiting NCT07375433

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Echocardiography, Spirometry, Body plethysmography, 6-Minute Walk Test (6MWT).
Who it may be relevant to
Registry conditions: COPD (Chronic Obstructive Pulmonary Disease), Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis). Basic parameters: 50 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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

Primary outcome measures

  • Primary composite endpoin [Time frame: 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Russia · 2 centers
  • Kazan State Medical University — Kazan'
  • National Medical Research Center for Therapy and Preventive Medicine — Moscow

Identifiers

NCT: NCT07375433 · 06-08/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗