NCT07389564

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

January 29, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 29, 2026

Last Update Submit

January 29, 2026

Conditions

Heart Failure

Keywords

heart failureregistryprognosis

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    All-cause mortality

    12 months

Secondary Outcomes (3)

  • Cardiovascular mortality

    12 months

  • HF decompensations

    12 months

  • Worsening of HF symptoms

    12 months

Study Arms (2)

Heart failure with improved ejection fraction

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%

Heart failure with supranormal ejection fraction

Patients with HF whose LVEF values on echocardiography are \>65%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Each participating center will enroll patients \> 18 years old retrospectively from their internal databases based on the clinical and echocardiographic diagnosis of HFimpEF and HFsnEF, but also prospectively for six months from the NOVEL-HF joining with informed consent of the patients.

You may qualify if:

  • HFimpEF or HFsnEF diagnosis

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow, Jagiellonian University Medical College

Krakow, 31-202, Poland

Location

Related Publications (2)

  • Stepien K, Eliasz K, Nowak K, Karcinska A, Kachnic N, Yika ADC, Platschek M, Krawczyk K, Siniarski A, Zalewski J, Nessler J. Clinical determinants and long-term survival in heart failure with supra-normal ejection fraction. Insights from LECRA-HF registry. Adv Med Sci. 2025 Mar;70(1):166-171. doi: 10.1016/j.advms.2025.02.005. Epub 2025 Feb 19.

    PMID: 39983867RESULT

  • Stepien K, Nowak K, Kachnic N, Karcinska A, Del Carmen Yika A, Furczynski J, Platschek M, Skorupa M, Wylecial Z, Zalewski J, Nessler J. Clinical characteristics and long-term outcomes of patients with heart failure with improved ejection fraction. First Polish experience from LECRA-HF registry. Adv Med Sci. 2024 Mar;69(1):132-138. doi: 10.1016/j.advms.2024.02.009. Epub 2024 Mar 4.

    PMID: 38447613RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 5, 2026

Study Start

January 29, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)