DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection Fraction

Recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF)

• Registration Number: NCT05792059
• Lead Sponsor: National Medical Research Center for Therapy and Preventive Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-09
• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-03-17
• Study First Posted: 2023-03-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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;

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
An increased of post-exercise E/e' ratio	during diastolic stress test (baseline)
An increased of post-exercise pulmonary artery systolic pressure (PASP)	during diastolic stress test (baseline)

Trial Locations

Locations (1)

National Medical Research Center for Therapy and Preventive Medicine; 🇷🇺 Moscow, Russian Federation