NCT05603390

Brief Summary

Heart failure (HF) affects about 1% of patients younger than 55 years, whereas the prevalence of HF increases \> 10% in patients with at least 70 years of age. Despite HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF), the clinical significance of HF with mildly reduced ejection fraction (HFmrEF) has gained more importance within the past years. Those patients are characterized by a left ventricular ejection fraction (LVEF) of 41-49%. However, within the current European guidelines, limited treatment recommendations in this subgroup of HF are yet available as a consequence of the limited number of studies in this field. The "Heart Failure With Mildly Reduced Ejection Fraction Registry" aims to characterize patients with HFmrEF and investigated the prognostic impact of interventional and pharmacological therapies in this subgroup of HF patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2015

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

7 years

First QC Date

October 10, 2022

Last Update Submit

October 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    All-cause mortality

    2 years.

Secondary Outcomes (3)

  • Change of LVEF

    2 years.

  • Change of NT-pro BNP

    2 years.

  • Heart-failure related hospitalization

    2 years.

Eligibility Criteria

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

The present study consecutively includes patients with heart failure with mildly reduced ejection fraction (HFmrEF) from 2015 to 2022.

You may qualify if:

  • Patients with HFmrEF (i.e., LVEF 41-49%)
  • Patients with at least 18 years of age

You may not qualify if:

  • Patients younger than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Mannheim

Mannheim, 68167, Germany

RECRUITING

Related Publications (2)

  • Schmitt A, Akin I, Reinhardt M, Abel N, Lau F, Dudda J, Abumayyaleh M, Weidner K, Bertsch T, Duerschmied D, Behnes M, Schupp T. Albumin, urea-to-albumin ratio, or the albumin-to-creatinine ratio to predict outcomes in heart failure with mildly reduced ejection fraction. Eur J Clin Invest. 2026 Jan;56(1):e70165. doi: 10.1111/eci.70165. Epub 2025 Dec 26.

  • Reinhardt M, Behnes M, Weidner K, Abumayyaleh M, Lau F, Schmitt A, Abel N, Duerschmied D, Weiss C, Akin M, Akin I, Schupp T. Prognostic Implications of Sex in Patients With Heart Failure With Mildly Reduced Ejection Fraction: Results From a Large-Scaled Registry. J Am Heart Assoc. 2025 Jan 21;14(2):e033173. doi: 10.1161/JAHA.123.033173. Epub 2025 Jan 16.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Michael Behnes, MD

    First Department of Medicine, University Medical Centre Mannheim, Germany.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Behnes, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Michael Behnes

Study Record Dates

First Submitted

October 10, 2022

First Posted

November 2, 2022

Study Start

January 1, 2015

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

November 2, 2022

Record last verified: 2022-10

Locations