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

NCT ID: NCT05792059

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-09

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Heart Failure With Preserved Ejection Fraction (HFpEF)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with HFpEF

No interventions assigned to this group

patients without HFpEF

No interventions assigned to this group

Eligibility Criteria

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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;
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Medical Research Center for Therapy and Preventive Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Medical Research Center for Therapy and Preventive Medicine

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Olga Dzhioeva

Role: CONTACT

+7 (916) 614-18-21

Facility Contacts

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Olga Dzhioeva

Role: primary

+79166141821

Other Identifiers

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01-02/23

Identifier Type: -

Identifier Source: org_study_id

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