Relationships and Differences Analysis in Heart Failure

• Conditions: Chronic Heart Disease; Heart Failure; Chronic Heart Failure
• Interventions: Other: Time (outcome)

• Registration Number: NCT03966729
• Lead Sponsor: Wuerzburg University Hospital

Brief Summary

This study characterizes heart failure patients who attended the University Hospital Würzburg. The primary aim is a better understanding of the relationships and differences between the subgroups HFrEF (EF \< 40%), HFmrEF (EF 40-49%), and HFpEF (EF\>50%), contributing to an improved diagnosis, prognosis and therapy of patients with heart failure.

Detailed Description

The varying clinical picture of heart failure (HF) represents a major challenge for patient care in Germany. HF is one of the most common reasons for hospitalization in the Western world. In the chronic course of heart failure, affected patients are committed to morbidity, lifelong therapy and high risk of cardiac decompensation, also associated with high mortality.

Heart failure patients, who visited the Cardiology Department of the University Hospital Wuerzburg, shall be analyzed with regard to all clinical data and outcome. This retrospective work should help to better understand the three groups HFrEF (EF \< 40%), HFmrEF (EF 40-49%) and HFpEF (EF\>50%) and help identifying similarities and differences between the groups.

Hereby we hope for progress in diagnostic, prognostic and therapeutic aspects of heart failure.

Study Timeline

• Study Start: 2009-01-01
• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-05-25
• Study First Posted: 2019-05-29
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-07
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Diagnosis: Heart failure
• Minimum of two echocardiographic examinations in a minimum time frame of six months
• Patients must have reached the age of 18

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HFmrEF	Time (outcome)	HFmrEF (Heart failure with mid-range reduced ejection fraction): ESC Guideline heart failure 2016: patients with LVEF 40-49%. LVEF = Left ventricular ejection fraction
HFrEF	Time (outcome)	HFrEF (Heart failure with reduced ejection fraction): ESC Guideline heart failure 2016: patients with LVEF \< 40%. LVEF = Left ventricular ejection fraction
HFpEF	Time (outcome)	HFmrEF (Heart failure with preserved ejection fraction): ESC Guideline heart failure 2016: patients with LVEF \> 50%. LVEF = Left ventricular ejection fraction

Primary Outcome Measures

Name	Time	Method
Long-term survival in heart failure patients with preserved, mid-range or reduced left ventricular ejection fraction	1 year follow up after last examination	Survival of patients with heart failure extracted from medical record or by telephone interview

Secondary Outcome Measures

Name	Time	Method
Impact of clinical imaging and laboratory parameters on long-term survival in heart failure patients with precerved, mid-range or reduced left ventricular ejection fraction	6 months	Parameters are derived from standard echocardiography, cardiac magnetic resonance imaging and blood testing.

Trial Locations

Locations (1)

University Hospital Würzburg; 🇩🇪 Würzburg, Bavaria, Germany