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Active, not recruiting Observational

Nationwide Registry of Patients With Heart Failure With Improved and Supranormal Ejection Fraction

NCT07389564 · tracked via the Priya Life Science Poland tracker
Phase
Observational
Started
2026-01-29
Last updated
2026-02-05

Condition(s) studied

Heart Failure

Study summary

NOVEL-HF is a multicenter, observational nationwide registry of HFimpEF and HFsnEF conducted in cooperation with the Scientific Platform of the Polish Society of Cardiology.

According to the current definitions the criteria for HFimpEF diagnosis include patients with HF with an initial left ventricular ejection fraction (LVEF) below 40%, with at least a 10% increase during follow-up, and with final values \>40%. HFsnEF includes patients with HF whose LVEF values on echocardiography are \>65%.

The patient data will be collected from standardized and anonymous forms via the Scientific Platform of the Polish Society of Cardiology. The NOVEL-HF registry will involve the complete clinical, laboratory, and echocardiographic characteristics, as well as introduced pharmacological treatment. The occurrence of end-points (all-cause mortality, cardiovascular mortality, HF decompensations, worsening of HF symptoms) will be assessed in short- and long-term follow-up.

In accordance with initial assumptions, 500 HFimpEF and 200 HFsnEF patients in all participating centers will be included.

Ethical approval was granted by the local Bioethics Committee.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * HFimpEF or HFsnEF diagnosis Exclusion Criteria: * None

Primary outcome measure(s)

  • All-cause mortality — 12 months
    All-cause mortality

Trial sites (1)

FacilityCityRegionStatus
Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow, Jagiellonian University Medical College Krakow Poland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07389564 on ClinicalTrials.gov ↗ ← All trials in Poland