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Status unknownNCT05603390HARMERUpdated Nov 2, 2022

Heart Failure With Mildly Reduced Ejection Fraction Registry

An observational study in Heart Failure, sponsored by Universitätsmedizin Mannheim. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-02.

Sponsored by Universitätsmedizin Mannheim · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,200
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 2,200 is above the median of 200 across 1,719 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Universitätsmedizin Mannheim is the lead sponsor of 78 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients younger than 18 years of age
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,200 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. All-cause mortality

    All-cause mortality

    Time frame: 2 years.

Secondary outcomes

  1. Change of LVEF

    Change of LVEF

    Time frame: 2 years.

  2. Change of NT-pro BNP

    Change of NT-pro BNP

    Time frame: 2 years.

  3. Heart-failure related hospitalization

    Heart-failure related hospitalization

    Time frame: 2 years.

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Study locations

1 of 1 sites recruiting
  • University Medical Centre Mannheim
    Mannheim, 68167, Germany
    • Michael Behnes, Prof. Dr. med. · Contact · michael.behnes@umm.de · +49 621-383-6239
    • Tobias Schupp, MD · Principal investigator
    Recruiting
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References and documents

Publications

  • Schmitt A, Behnes M, Reinhardt M, Abel N, Lau F, Weidner K, Abumayyaleh M, Hagmann M, Akin I, Schupp T. Different diuretic regimes and long-term outcomes in heart failure with mildly reduced ejection fraction. Curr Med Res Opin. 2026 Sep 14:1-12. doi: 10.1080/03007995.2026.2730837. Online ahead of print. PubMed 42735070 ↗
  • 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. PubMed 41452958 ↗
  • Abel N, Behnes M, Schmitt A, Reinhardt M, Lau F, Weidner K, Ayoub M, Mashayekhi K, Bertsch T, Akin I, Schupp T. Predictors and prognosis of progression of aortic valve stenosis in patients hospitalized with heart failure with mildly reduced ejection fraction. Cardiovasc Revasc Med. 2025 Oct;79:90-97. doi: 10.1016/j.carrev.2025.05.028. Epub 2025 May 29. PubMed 40473554 ↗
  • 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. PubMed 39817535 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2015 to primary completion in Jan 2022, 84 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2022
First posted
Nov 2, 2022
StartActual
Jan 1, 2015
Primary completionActual
Jan 1, 2022
CompletionEst.
Jan 1, 2023
Last update
Nov 2, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05603390
Lead sponsor
Universitätsmedizin Mannheim
Responsible party
Michael Behnes (Prof. Dr. med. Michael Behnes, Universitätsmedizin Mannheim) — Principal investigator
First posted
Nov 2, 2022
Start date
Jan 1, 2015
Primary completion
Jan 1, 2022
Completion
Jan 1, 2023 (estimated)
Last update
Nov 2, 2022

Study contacts

Michael Behnes, MD
Contact
michael.behnes@umm.de
+496213836239
Michael Behnes, MD
principal investigator · First Department of Medicine, University Medical Centre Mannheim, Germany.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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