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Clinical Trials/NCT05792059
NCT05792059
Recruiting
Not Applicable

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

National Medical Research Center for Therapy and Preventive Medicine1 site in 1 country80 target enrollmentFebruary 9, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure With Preserved Ejection Fraction (HFpEF)
Sponsor
National Medical Research Center for Therapy and Preventive Medicine
Enrollment
80
Locations
1
Primary Endpoint
An increased of post-exercise E/e' ratio
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 9, 2023
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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;

Outcomes

Primary Outcomes

An increased of post-exercise E/e' ratio

Time Frame: during diastolic stress test (baseline)

An increased of post-exercise pulmonary artery systolic pressure (PASP)

Time Frame: during diastolic stress test (baseline)

Study Sites (1)

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