Predictors of Poor Prognosis in HFpEF

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

Status: Enrolling

Conditions: HFpEF

Study type: Observational

Funder types: Other

Identifiers

NCT06844032

AAAA-A18-118022290061-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

400 participants in 2 patient groups

with primary outcome

Description:

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

without primary outcome

Description:

Patients with HFpEF who survived without hospitalization for HF