Clinical trial NCT06844032: Predictors of Poor Prognosis in HFpEF
Official title: Clinical, Hemodynamic and Neurohumoral Predictors of Poor Prognosis in Heart Failure with Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HFpEF
Keywords: HFpEF
HF
diastolic dysfunction
left ventricle (LV) filling pressures
left ventricular hypertrophy
cardiac reserves
myocardial fibrosis
Lead sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Sponsor class: OTHER_GOV
First posted: 2025-02-25
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospitalization for exacerbation of HF
timeFrame: From enrollment to August 2025
measure: All-cause mortality
timeFrame: From enrollment to August 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: 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
Study officials:
References: