check_circleStudy Completed
Heart Failure
Bayer Identifier:
18428
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Chronic Heart Failure Burden of illness and Treatment Patterns
Trial purpose
The study aims to address questions related to the current burden of illness, treatment patterns and unmet needs in a contemporary heart failure population.The primary objective of the study is to better understand the patient characteristics, treatment patterns, and clinical outcomes of HF patients with preserved ejection fraction (>45%) [HFpEF] and HF patients with reduced ejection fraction (=>45%) [HFrEF] patients.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
336000Trial Dates
May 2016 - March 2017Phase
N/ACould I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoPrimary Outcome
- HospitalizationProportion of HF patient requiring hospitalization (heart failure related or otherwise)date_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Composite of HF-related hospitalization and MortalityProportion of HF patients having a fatal event or HF-related hospitization following cohort entry.date_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- HF-related burden of illnessCox PH models will be used to understand burden of illness as it relates to readmissions, mortality, renal dysfunction, hyperkalemia, and elevated levels of BNP and NT proBNPdate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Usage and predictors of Mineralocorticoid Receptor Antagonist (MRA)Proportion of patients with MRA usage 30 days & 365 days following index event. Predictors: demographic variables and co-morbidities, prior HF hospitalisation, ejection fraction, prior hyperkalemia, HF medication class usage. The medication usage includes the dosage, timing of therapy, and duration and frequency of therapy.date_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Usage and predictors of Isosorbide dinitrate/Hydralazine hydrochloride (BiDil)Proportion of patients with MRA usage 30 days & 365 days following index event. Predictors: demographic variables and co-morbidities, prior HF hospitalisation, ejection fraction, prior hyperkalemia, HF medication class usage. The medication usage includes the dosage, timing of therapy, and duration and frequency of therapy.date_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Usage and predictors of Long-Acting NitratesProportion of patients with MRA usage 30 days & 365 days following index event. Predictors: demographic variables and co-morbidities, prior HF hospitalisation, ejection fraction, prior hyperkalemia, HF medication class usage. The medication usage includes the dosage, timing of therapy, and duration and frequency of therapy.date_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Change in potassium concentration valuesProportion of patients with potassium lab values >5.5mmol/L. Predictors: demographic variables, prior HF hospitalisation, ejection fraction, HF medication class usage including MRA usage.date_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Change in renal functionSummary statistics of eGFR lab values over time:Predictors: demographic variables, prior HF hospitalisation, ejection fraction, HF medication class usage including MRA usage.date_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Change in Brain Natriuretic Peptide concentration values over time : -30 to -1 Days, 0 to 30 Days, 31 to 90 Days, 91 to 182 Days, 183 to 365 DaysSummary statistics of BNP lab reading over time:.. 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF valuesdate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Change in N-terminal pro B-type Natriuretic Peptide concentration values over time : -30 to -1 Days, 0 to 30 Days, 31 to 90 Days, 91 to 182 Days, 183 to 365 DaysSummary statistics of BNP lab reading over time:.. 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF valuesdate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Treatment Patterns: % of patients Using Angiotensin-Converting Enzyme (ACE) InhibitorsProportion of patients with recorded usage of guideline recommended standard of care HF medications, within 30 & 365 days: 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF values 4. HF patients with diabetes 5. HF patients with non-diabetes 6. HF patients with kidney disease 7. HF patients with non-kidney diseasedate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Treatment Patterns: % of patients Using Angiotensin II Receptor Blockers (ARB)Proportion of patients with recorded usage of guideline recommended standard of care HF medications, within 30 & 365 days: 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF values 4. HF patients with diabetes 5. HF patients with non-diabetes 6. HF patients with kidney disease 7. HF patients with non-kidney diseasedate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Treatment Patterns: % of patients Using ACE or ARBProportion of patients with recorded usage of guideline recommended standard of care HF medications, within 30 & 365 days: 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF values4. HF patients with diabetes 5. HF patients with non-diabetes 6. HF patients with kidney diease 7. HF patients with non-kidney diseasedate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Treatment Patterns: % of patients Using Beta BlockersProportion of patients with recorded usage of guideline recommended standard of care HF medications, within 30 & 365 days: 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF values 4. HF patients with diabetes 5. HF patients with non-diabetes 6. HF patients with kidney disease 7. HF patients with non-kidney diseasedate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Treatment Patterns: % of patients Using Calcium Channel BlockersProportion of patients with recorded usage of guideline recommended standard of care HF medications, within 30 & 365 days: 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF values 4. HF patients with diabetes 5. HF patients with non-diabetes 6. HF patients with kidney disease 7. HF patients with non-kidney diseasedate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Treatment Patterns: % of patients Using SpironolactoneProportion of patients with recorded usage of guideline recommended standard of care HF medications, within 30 & 365 days: 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF values 4. HF patients with diabetes 5. HF patients with non-diabetes 6. HF patients with kidney disease 7. HF patients with non-kidney diseasedate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Treatment Patterns: % of patients Using EplerenoneProportion of patients with recorded usage of guideline recommended standard of care HF medications, within 30 & 365 days: 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF values 4. HF patients with diabetes 5. HF patients with non-diabetes 6. HF patients with kidney disease 7. HF patients with non-kidney diseasedate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Treatment Patterns: % of patients Using Loop DiureticsProportion of patients with recorded usage of guideline recommended standard of care HF medications, within 30 & 365 days: 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF values 4. HF patients with diabetes 5. HF patients with non-diabetes 6. HF patients with kidney disease 7. HF patients with non-kidney diseasedate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Treatment Patterns: % of patients Using Long-Acting NitratesProportion of patients with recorded usage of guideline recommended standard of care HF medications, within 30 & 365 days: 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF values 4. HF patients with diabetes 5. HF patients with non-diabetes 6. HF patients with kidney disease 7. HF patients with non-kidney diseasedate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Treatment Patterns: % of patients using Vitamin K Antagonist treatment HF medicationProportion of patients with recorded usage of guideline recommended standard of care HF medications, within 30 & 365 days: 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF values 4. HF patients with diabetes 5. HF patients with non-diabetes 6. HF patients with kidney disease 7. HF patients with non-kidney diseasedate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Treatment Patterns: % of patients using Novel Oral Anti-coagulant (NOAC) medicationProportion of patients with recorded usage of guideline recommended standard of care HF medications, within 30 & 365 days: 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF values 4. HF patients with diabetes 5. HF patients with non-diabetes 6. HF patients with kidney disease 7. HF patients with non-kidney diseasedate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Treatment Patterns: % of patients not Using Specified HF MedicationProportion of patients with recorded usage of guideline recommended standard of care HF medications, within 30 & 365 days: 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF values 4. HF patients with diabetes 5. HF patients with non-diabetes 6. HF patients with kidney disease 7. HF patients with non-kidney diseasedate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
- Usage of Medical Devices: Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT)Proportion of patients with recorded usage of guideline recommended standard of care HF medications, within 30 & 365 days: 1. HF patients with reduced ejection fraction (<45%) 2.HF patients with preserved ejection fraction (>=45%) 3. No EF: Patients with no valid LVEF values 4. HF patients with diabetes 5. HF patients with non-diabetes 6. HF patients with kidney disease 7. HF patients with non-kidney diseasedate_rangeTime Frame:Retrospective database analysis encompassing data from approximately 5 yearsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A