Predictors of Poor Prognosis in HFpEF

NCT ID: NCT06844032

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2025-12-31

Brief Summary

Patients with HFpEF who have undergone meticulous clinical and instrumental evaluation (including diastolic exercise testing) between 2013 and 2020, will be followed up for at least 3 years.

Detailed Description

Heart failure with preserved ejection fraction (HFpEF) is a serious condition with an unfavorable prognosis.

The investigators aimed to evaluate in patients with HFpEF:

• the prognostic significance of standard resting hemodynamic parameters compared to key cardiac reserves;
• the prognostic significance of clinical parameters (sex, age, NYHA class, extra-cardiac diseases, therapy);
• the prognostic significance of biological markers of hemodynamic stress and biomarkers of inflammation and fibrosis;
• to identify independent predictors of adverse prognosis of HFpEF.

Conditions

HFpEF

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

with primary outcome

Patients with HFpEF who experienced primary outcome (were hospitalized for HF or died)

No interventions assigned to this group

without primary outcome

Patients with HFpEF who survived without hospitalization for HF

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Signed and data informed consent;

2. New York Heart Association (NYHA) class II-III heart failure;

3. Left ventricular ejection fraction > 50%;

4. Elevated LV filling pressures assessed by echocardiography at rest or at peak exercise.

Exclusion Criteria

1. Evidence of myocardial ischemia during stress echocardiography;

2. Significant lesions of the main coronary arteries;

3. Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.);

4. Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided HF without left-sided structural disease, constrictive pericarditis, significant pericardial effusion;

5. Significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy);

6. Primary pulmonary artery hypertension;

7. Significant left-sided structural valve disease;

8. Anemia (Hb < 100 g/L);

9. Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (CKD-EPI);

10. Non-cardiac conditions that complicate/exclude participation in the study;

11. Exacerbation of heart failure less than 3 months prior to study entry.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anastasiia Filatova, MD, PhD

principal investigator, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADEMICIAN E.I.CHAZOV. of the Ministry of Health of the Russian Federation

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Artem G Ovchinnikov, MD, PhD, DSc

Role: CONTACT

artcardio@mail.ru

+74954146612

Facility Contacts

Artem Ovchinnikov, MD, PhD, DSc

Role: primary

artcardio@mail.ru

Other Identifiers

AAAA-A18-118022290061-03

Identifier Type: -

Identifier Source: org_study_id