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

NCT05792059 | Unknown

• 1 other identifier: 01-02/23
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

patients with HFpEF

patients without HFpEF

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead

Study Sites (1)

National Medical Research Center for Therapy and Preventive Medicine

Moscow, Russia

RECRUITING

Central Study Contacts

Olga Dzhioeva

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start: February 9, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

RU (1)