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Recruiting NCT06844032

Predictors of Poor Prognosis in HFpEF

Conditions: HFpEF

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

trial.available_in: БГ
Overview
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.
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.
Who can participate
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.
Locations 1
Russia (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
Artem Ovchinnikov, MD, PhD, DSc
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
40 Years
Healthy volunteers
No
Start date
31.01.2022
Completion date
31.12.2026
Registry ID
NCT06844032
Source
clinicaltrials.gov
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