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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05792059

Acronym

EMPATHY-HF

Enrollment

Registered

2023-03-30

Start date

2023-02-09

Completion date

2023-12-31

Last updated

2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

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;

Design outcomes

Primary

Measure	Time frame
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)

Countries

Russia

Contacts

Primary ContactOlga Dzhioeva

odzhioeva@gnicpm.ru+7 (916) 614-18-21

Outcome results