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Heart FailureHARMERNCT05603390

Heart Failure With Mildly Reduced Ejection Fraction Registry

An observational study of Heart Failure, run by Universitätsmedizin Mannheim at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
How many people
2,200 participants
Where
1 siteGermany
Study dates
1 Jan 2015to 1 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patients younger than 18 years of age

Trial locations and contacts

1 site in 1 country.

Michael Behnes, MD contact

+496213836239

michael.behnes@umm.de

Germany1 site, 1 recruiting

  • University Medical Centre Mannheim

    Mannheim, 68167

    Michael Behnes, Prof. Dr. med., +49 621-383-6239, michael.behnes@umm.de

    Tobias Schupp, MD

    Recruiting

Other trials in Germany

About this study

Official title: Heart Failure With Mildly Reduced Ejection Fraction Registry (HARMER)

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.

Conditions
Heart Failure
Medical subject headings
Heart Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    All-cause mortality

    Measured: 2 years.

Secondary outcomes (3)

  1. Change of LVEF

    Change of LVEF

    Measured: 2 years.

  2. Change of NT-pro BNP

    Change of NT-pro BNP

    Measured: 2 years.

  3. Heart-failure related hospitalization

    Heart-failure related hospitalization

    Measured: 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2022
  2. Study start1 Jan 2015
  3. Primary completion1 Jan 2022
  4. Study completion1 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
2,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05603390
Sponsor's protocol ID
2022-818
Acronym
HARMER
Status last verified
Oct 2022
First submitted
10 Oct 2022
Last updated
2 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Universitätsmedizin Mannheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michael Behnes, MD (+496213836239, michael.behnes@umm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05603390, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.

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