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

National Medical Research Center for Therapy and Preventive Medicine

Status: Enrolling

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

Treatments: Diagnostic Test: Body plethysmography; Diagnostic Test: laboratory biomarker analysis; Diagnostic Test: Echocardiography; Diagnostic Test: Spirometry; Diagnostic Test: 6-Minute Walk Test (6MWT)

Study type: Observational

Funder types: Other

Identifiers

NCT07375433

06-08/25

Details and patient eligibility

About

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.

Full 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.

We assume that newly diagnosed HFpEF will occur in at least 6% (COPD PRIORITY data) of cases, and, in our opinion, 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Patients with Сhronic Obstructive Pulmonary Disease

Description:

Patients hospitalized with a verified diagnosis of COPD. Patients with a confirmed diagnosis in accordance with instrumental and clinical criteria.

Treatment:

Diagnostic Test: 6-Minute Walk Test (6MWT)

Diagnostic Test: Spirometry

Diagnostic Test: Echocardiography

Diagnostic Test: laboratory biomarker analysis

Diagnostic Test: Body plethysmography