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

Sponsor
National Medical Research Center for Therapy and Preventive Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05792059
Collaborator
(none)
80
Enrollment
1
Location
10.7
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection Fraction (EMPATHY-HF)
    Actual Study Start Date :
    Feb 9, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    patients with HFpEF
    patients without HFpEF

    Outcome Measures

    Primary Outcome Measures

    1. An increased of post-exercise E/e' ratio [during diastolic stress test (baseline)]

    2. An increased of post-exercise pulmonary artery systolic pressure (PASP) [during diastolic stress test (baseline)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Medical Research Center for Therapy and Preventive Medicine Moscow Russian Federation

    Sponsors and Collaborators

    • National Medical Research Center for Therapy and Preventive Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Medical Research Center for Therapy and Preventive Medicine
    ClinicalTrials.gov Identifier:
    NCT05792059
    Other Study ID Numbers:
    • 01-02/23
    First Posted:
    Mar 30, 2023
    Last Update Posted:
    Apr 6, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Apr 6, 2023