Heart Failure With Mildly Reduced Ejection Fraction Registry

Heart Failure Clinical Trial

— HARMER  

Official title:

Heart Failure With Mildly Reduced Ejection Fraction Registry (HARMER)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05603390
• Other study ID #: 2022-818
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: January 1, 2023

Study information

• Verified date: October 2022
• Source: Universitätsmedizin Mannheim
• Contact: Michael Behnes, MD
• Phone: +496213836239
• Email: michael.behnes[@]umm.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Germany	University Medical Centre Mannheim	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	All-cause mortality	2 years.
Secondary	Change of LVEF	Change of LVEF	2 years.
Secondary	Change of NT-pro BNP	Change of NT-pro BNP	2 years.
Secondary	Heart-failure related hospitalization	Heart-failure related hospitalization	2 years.