Heart Failure With Mildly Reduced Ejection Fraction Registry (HARMER)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure

• Study Type: Observational
• Enrollment (Anticipated): 2200

Contacts and Locations

• Study Contact: Name: Michael Behnes, MD; Phone Number: +496213836239; Email: michael.behnes@umm.de

Study Locations

• Germany
  • Mannheim, Germany, 68167
    • Recruiting
    • University Medical Centre Mannheim
    • Contact: Michael Behnes, Prof. Dr. med.; Phone Number: +49 621-383-6239; Email: michael.behnes@umm.de
    • Principal Investigator: Tobias Schupp, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients younger than 18 years of age

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality	2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of LVEF	Change of LVEF	2 years.
Change of NT-pro BNP	Change of NT-pro BNP	2 years.
Heart-failure related hospitalization	Heart-failure related hospitalization	2 years.

Collaborators and Investigators

• Sponsor: Universitätsmedizin Mannheim
• Investigators: Principal Investigator: Michael Behnes, MD, First Department of Medicine, University Medical Centre Mannheim, Germany.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 30, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 30, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2022-818

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No