Relationships and Differences Analysis in Heart Failure (REDEAL-HF)

Retrospektive Datenanalyse Von Herzinsuffizienzpatienten in Der Kardiologie Des Universitätsklinikums Würzburg

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Chronic Heart Failure; Chronic Heart Disease
• Intervention / Treatment: Other: Time (outcome)

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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Peter Nordbeck, MD, PhD; Phone Number: +49 931 201 39181; Email: nordbeck_p@ukw.de
• Study Contact Backup: Name: Kai Hu, MD; Phone Number: +49 931 201 0; Email: hu_k@ukw.de

Study Locations

• Germany
  • Bavaria
    • Würzburg, Bavaria, Germany, 97080
      • Recruiting
      • University Hospital Würzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Our cohort consists of patients who attended the Cardiology Department of University Hospital Wuerzburg in the time period between 2009 and 2019.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Parameters are derived from standard echocardiography, cardiac magnetic resonance imaging and blood testing.	6 months

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Investigators: Study Chair: Peter Nordbeck, MD, PhD, Wuerzburg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: May 25, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Heart Failure; HFrEF; HFpEF; HFmrEF
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Failure; Heart Diseases
• Other Study ID Numbers: REDEAL-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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