Heart FailureREDEAL-HFNCT03966729
Relationships and Differences Analysis in Heart Failure
An observational study of Heart Failure and Chronic Heart Failure, run by Wuerzburg University Hospital at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Chronic Heart Failure, Chronic Heart Disease
- What is being tested?
- Time (outcome)
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2009to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our cohort consists of patients who attended the Cardiology Department of University Hospital Wuerzburg in the time period between 2009 and 2019.
Who may be able to join
- Diagnosis: Heart failure
- Minimum of two echocardiographic examinations in a minimum time frame of six months
- Patients must have reached the age of 18
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Würzburg
Würzburg, Bavaria, 97080
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure, Chronic Heart Failure, Chronic Heart Disease
- Being tested
- Time (outcome)
- Keywords
- HFmrEF, HFrEF, HFpEF, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time (outcome)Other
| Study group | Role | What they receive |
|---|---|---|
| HFrEF | HFrEF (Heart failure with reduced ejection fraction): ESC Guideline heart failure 2016: patients with LVEF < 40%.
LVEF = Left ventricular ejection fraction Receives: 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 Receives: 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 Receives: Other: Time (outcome) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Parameters are derived from standard echocardiography, cardiac magnetic resonance imaging and blood testing.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Jan 2009
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Peter Nordbeck, Wuerzburg University Hospital
- Investigators
- Peter Nordbeck, MD, PhD, Study chair, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966729
- Sponsor's protocol ID
- REDEAL-HF
- Acronym
- REDEAL-HF
- Status last verified
- Jul 2022
- First submitted
- 4 Feb 2019
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospektive Datenanalyse Von Herzinsuffizienzpatienten in Der Kardiologie Des Universitätsklinikums Würzburg
- ClinicalTrials.gov ID
- NCT03966729
- Acronym / sponsor ID
- REDEAL-HF / REDEAL-HF
- Conditions
- Heart Failure, Chronic Heart Failure, Chronic Heart Disease
- Keywords
- HFmrEF, HFrEF, HFpEF, Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFrEF | – | Other: Time (outcome)HFrEF (Heart failure with reduced ejection fraction): ESC Guideline heart failure 2016: patients with LVEF < 40%. LVEF = Left ventricular ejection fraction |
| HFmrEF | – | Other: 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 |
| HFpEF | – | Other: Time (outcome)HFmrEF (Heart failure with preserved ejection fraction): ESC Guideline heart failure 2016: patients with LVEF > 50%. LVEF = Left ventricular ejection fraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our cohort consists of patients who attended the Cardiology Department of University Hospital Wuerzburg in the time period between 2009 and 2019.
Key inclusion criteria (3 listed)
- Diagnosis: Heart failure
- Minimum of two echocardiographic examinations in a minimum time frame of six months
- Patients must have reached the age of 18
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time (outcome) | Other | HFmrEF, HFpEF, HFrEF |
Primary outcome
Long-term survival in heart failure patients with preserved, mid-range or reduced left ventricular ejection fraction
Time frame: 1 year follow up after last examination
Survival of patients with heart failure extracted from medical record or by telephone interview
1 secondary outcome
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
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Nordbeck, MD, PhD study chair
Wuerzburg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Chronic Heart Failure, run by Wuerzburg University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Nordbeck, MD, PhD (+49 931 201 39181, nordbeck_p@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term survival in heart failure patients with preserved, mid-range or reduced left ventricular ejection fraction (time frame: 1 year follow up after last examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.