NCT03966729

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

15 years

First QC Date

February 4, 2019

Last Update Submit

July 6, 2022

Conditions

Heart FailureChronic Heart FailureChronic Heart Disease

Keywords

HFmrEFHFrEFHFpEFHeart Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (3)

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)

Interventions

Time (outcome)OTHER
HFmrEFHFpEFHFrEF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Würzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Time

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Peter Nordbeck, MD, PhD

    Wuerzburg University Hospital

    STUDY CHAIR

Central Study Contacts

Peter Nordbeck, MD, PhD

CONTACT

+49 931 201 39181nordbeck_p@ukw.de

Kai Hu, MD

CONTACT

+49 931 201 0hu_k@ukw.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Consultant Cardiology

Study Record Dates

First Submitted

February 4, 2019

First Posted

May 29, 2019

Study Start

January 1, 2009

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 7, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)