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DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection Fraction (EMPATHY-HF)

N

National Medical Research Center for Therapy and Preventive Medicine

Status

Enrolling

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Study type

Observational

Funder types

Other

Identifiers

NCT05792059
01-02/23

Details and patient eligibility

About

Prevalence of heart failure with preserved ejection fraction (HFpEF) continues to increase in the developed world, likely because of the increasing life expectancy and an increasing number of elderly patients.

Transthoracic echocardiography is essential for the diagnosis of HFpEF according to the current guidelines. The HFA-PEFF and H2FPEF diagnostic algorithms rely on clinical characteristics and echocardiography findings that indicate the presence of diastolic dysfunction.

These diagnostic algorithms are not applicable in remote areas where expert echocardiography cannot be performed due to the absence of modern ultrasound systems and lack of qualified specialists. Therefore, it is important to develop an algorithm to evaluate pre-test probability of HFpEF without echocardiographic markers, so it can be easily used in the primary outpatient care setting by any specialist.

The aim of this study is to find the associations between clinical and epidemiological characteristics and changes of intracardiac hemodynamics in patients with dyspnea and decreased exercise tolerance.

Enrollment

80 estimated patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients complaining of shortness of breath, with two or more chronic non-communicable diseases (patients with comorbidities)

Exclusion criteria

  • Morbid obesity;
  • Any chronic diseases in the stage of exacerbation and / or decompensation;
  • Systemic diseases, cancer;
  • Cardiac arrhythmias: persistent atrial fibrillation or paroxysmal atrial fibrillation with frequent paroxysms;
  • History of myocardial infarction, stroke, heart failure with reduced ejection fraction;
  • Storage diseases, hypertrophic cardiomyopathy, concentric hypertrophy;
  • Congenital and acquired heart defect;

Trial design

80 participants in 2 patient groups

patients with HFpEF
patients without HFpEF

Trial contacts and locations

1

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Central trial contact

Olga Dzhioeva

Data sourced from clinicaltrials.gov

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