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NCT Number: NCT06844032

Predictors of Poor Prognosis in HFpEF

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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, 121552, Russia

Location status: Recruiting

Location contact

Artem Ovchinnikov, MD, PhD, DSc

CONTACT

[email protected]

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Hospitalization for exacerbation of HF

    Time frame: From enrollment to August 2026

  2. All-cause mortality

    Time frame: From enrollment to August 2026

Study contacts

Contact information is provided by the study sponsor or research team.

Artem G Ovchinnikov, MD, PhD, DSc

CONTACT

[email protected]

+74954146612

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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