Identifying predictors of poor prognosis in heart failure with preserved ejection fraction

Clinical, Hemodynamic and Neurohumoral Predictors of Poor Prognosis in Heart Failure With Preserved Ejection Fraction

This study is trying to find out which factors can help predict bad outcomes for people with heart failure who have preserved ejection fraction.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation (other gov)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Moscow)
• Trial ID: NCT06844032 on ClinicalTrials.gov

What this trial studies

This observational study follows patients diagnosed with heart failure with preserved ejection fraction (HFpEF) who have undergone thorough clinical and instrumental evaluations from 2013 to 2020. The aim is to assess the prognostic significance of various hemodynamic parameters, clinical characteristics, and biological markers in predicting adverse outcomes in HFpEF patients. Participants will be monitored for at least three years to identify independent predictors of poor prognosis. The study focuses on understanding how different factors contribute to the severity and progression of HFpEF.

Who should consider this trial

Good fit: Ideal candidates include individuals with NYHA class II-III heart failure and left ventricular ejection fraction greater than 50%.

Not a fit: Patients with significant coronary artery disease, genetic forms of HFpEF, or other specified exclusions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved risk stratification and management strategies for patients with HFpEF.

How similar studies have performed: While there have been studies on HFpEF, this specific approach focusing on a comprehensive evaluation of prognostic factors is relatively novel.

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.

Where this trial is running

Moscow

• 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 (RECRUITING)

Study contacts

• Study coordinator: Artem G Ovchinnikov, MD, PhD, DSc

Conditions: HFpEF, HF, diastolic dysfunction, left ventricle filling pressures, left ventricular hypertrophy, cardiac reserves, myocardial fibrosis