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

Heart Failure With Preserved Ejection Fraction (HFpEF) Clinical Trial

— EMPATHY-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05792059
• Other study ID #: 01-02/23
• Status: Recruiting
• Start date: February 9, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: National Medical Research Center for Therapy and Preventive Medicine
• Contact: Olga Dzhioeva
• Phone: +7 (916) 614-18-21
• Email: odzhioeva[@]gnicpm.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Russian Federation	National Medical Research Center for Therapy and Preventive Medicine	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Medical Research Center for Therapy and Preventive Medicine

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	An increased of post-exercise E/e' ratio		during diastolic stress test (baseline)
Primary	An increased of post-exercise pulmonary artery systolic pressure (PASP)		during diastolic stress test (baseline)