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Relationships and Differences Analysis in Heart Failure (REDEAL-HF)
| Condition or disease | Intervention/treatment |
|---|---|
| Heart Failure Chronic Heart Failure Chronic Heart Disease | Other: Time (outcome) |
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 |
| Estimated Enrollment : | 3000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Retrospektive Datenanalyse Von Herzinsuffizienzpatienten in Der Kardiologie Des Universitätsklinikums Würzburg |
| Actual Study Start Date : | January 1, 2009 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
| 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) |
- 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
- 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 ]Parameters are derived from standard echocardiography, cardiac magnetic resonance imaging and blood testing.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
| Contact: Peter Nordbeck, MD, PhD | +49 931 201 39181 | nordbeck_p@ukw.de | |
| Contact: Kai Hu, MD | +49 931 201 0 | hu_k@ukw.de |
| Germany | |
| University Hospital Würzburg | Recruiting |
| Würzburg, Bavaria, Germany, 97080 | |
| Study Chair: | Peter Nordbeck, MD, PhD | Wuerzburg University Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | February 4, 2019 | ||||||||
| First Posted Date | May 29, 2019 | ||||||||
| Last Update Posted Date | November 24, 2020 | ||||||||
| Actual Study Start Date | January 1, 2009 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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 ] Parameters are derived from standard echocardiography, cardiac magnetic resonance imaging and blood testing.
|
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Relationships and Differences Analysis in Heart Failure | ||||||||
| Official Title | Retrospektive Datenanalyse Von Herzinsuffizienzpatienten in Der Kardiologie Des Universitätsklinikums Würzburg | ||||||||
| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. | ||||||||
| Condition |
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| Intervention | Other: Time (outcome) | ||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
3000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2021 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Germany | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03966729 | ||||||||
| Other Study ID Numbers | REDEAL-HF | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | PD Dr. Peter Nordbeck, Wuerzburg University Hospital | ||||||||
| Study Sponsor | Wuerzburg University Hospital | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Wuerzburg University Hospital | ||||||||
| Verification Date | November 2020 | ||||||||
