Predictors of Poor Prognosis in HFpEF
Recruiting · NCT06844032 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is 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.
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- 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