Heart Failure With Mildly Reduced Ejection Fraction Registry | NCT05603390

Studies
Heart Failure With Mildly Reduced Ejection Fraction Registry

NCT05603390

Sponsor

Universitätsmedizin Mannheim

Status

Unknown status

Last Update Posted

Nov 2, 2022Actual

Enrollment

2,200Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Jan 1, 2023Estimated

First Submitted Date

Oct 10, 2022

First Submission Date that Met QC Criteria

Oct 30, 2022

First Posted Date

Nov 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2022

Last Update Posted Date

Nov 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Behnes, Prof. Dr. med. Michael Behnes, Universitätsmedizin MannheimPrincipal Investigator

Lead Sponsor

Universitätsmedizin MannheimOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,200Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change of LVEF	Change of LVEF	2 years.
Change of NT-pro BNP	Change of NT-pro BNP	2 years.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Behnes, MD	Contact	+496213836239		michael.behnes@umm.de

Overall Officials

Name	Affiliation	Role
Michael Behnes, MD	First Department of Medicine, University Medical Centre Mannheim, Germany.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Mannheim	Recruiting	Mannheim		68167	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41452958	Derived	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.
40473554

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases