Predictors of Poor Prognosis in HFpEF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HFpEF. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical, Hemodynamic and Neurohumoral Predictors of Poor Prognosis in Heart Failure With Preserved Ejection Fraction
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.
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.
Primary outcome measures
- Hospitalization for exacerbation of HF [Time frame: From enrollment to August 2026]
- All-cause mortality [Time frame: From enrollment to August 2026]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED A — Moscow
Identifiers
NCT: NCT06844032 · AAAA-A18-118022290061-03