Predictors of Poor Prognosis in HFpEF

NCT06844032 | Recruiting

• 1 other identifier: AAAA-A18-118022290061-03
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

HFpEF

Keywords

HFpEF; HF; diastolic dysfunction; left ventricle (LV) filling pressures; left ventricular hypertrophy; cardiac reserves; myocardial fibrosis

Outcome Measures

Primary Outcomes (2)

• Hospitalization for exacerbation of HF

  From enrollment to August 2026

• All-cause mortality

  From enrollment to August 2026

Study Arms (2)

with primary outcome

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

without primary outcome

Patients with HFpEF who survived without hospitalization for HF

Eligibility Criteria

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

Study Population

Outpatients with HFpEF who underwent meticulous clinical evaluation between 2013 and 2020 at the National Medical Research Centre for Cardiology (Moscow, Russian Federation)

You may qualify if:

• Signed and data informed consent;
• New York Heart Association (NYHA) class II-III heart failure;
• Left ventricular ejection fraction \> 50%;
• Elevated LV filling pressures assessed by echocardiography at rest or at peak exercise.

You may not qualify if:

• Evidence of myocardial ischemia during stress echocardiography;
• Significant lesions of the main coronary arteries;
• Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.);
• Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided HF without left-sided structural disease, constrictive pericarditis, significant pericardial effusion;
• Significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy);
• Primary pulmonary artery hypertension;
• Significant left-sided structural valve disease;
• Anemia (Hb \< 100 g/L);
• Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (CKD-EPI);
• Non-cardiac conditions that complicate/exclude participation in the study;
• Exacerbation of heart failure less than 3 months prior to study entry.

Sponsors & Collaborators

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

Study Sites (1)

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, 121552, Russia

RECRUITING

MeSH Terms

Conditions

Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Artem G Ovchinnikov, MD, PhD, DSc

CONTACT

+74954146612; artcardio@mail.ru

Study Design

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

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: January 31, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

RU (1)