Trial Condition(s):
Heart Failure
Chronic Heart Failure Burden of illness and Treatment Patterns
Bayer Identifier:
18428
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
Inclusion Criteria
- Adult patients who have been diagnosed with Heart Failure in a routine clinical practice database in the United States of America.
Exclusion Criteria
- Patients who did not have any medical record in the system more than 30 days prior to their first heart failure diagnosis.
Trial Summary
Enrollment Goal
336000
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Unspecified
Accepts Healthy Volunteers
No
Where to Participate
Locations
Status
| Locations | Status |
|---|
Trial Design
Chronic Heart Failure Burden of illness and Treatment Patterns; a Study Using Real World Data
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
7
Primary Outcome
- HospitalizationProportion of HF patient requiring hospitalization (heart failure related or otherwise)Timeframe: Retrospective database analysis encompassing data from approximately 5 years
- Composite of HF-related hospitalization and MortalityProportion of HF patients having a fatal event or HF-related hospitization following cohort entry.Timeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 proBNPTimeframe: Retrospective database analysis encompassing data from approximately 5 years
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.Timeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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.Timeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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.Timeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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.Timeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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.Timeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 valuesTimeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 valuesTimeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 diseaseTimeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 diseaseTimeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 diseaseTimeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 diseaseTimeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 diseaseTimeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 diseaseTimeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 diseaseTimeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 diseaseTimeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 diseaseTimeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 diseaseTimeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 diseaseTimeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 diseaseTimeframe: Retrospective database analysis encompassing data from approximately 5 years
- 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 diseaseTimeframe: Retrospective database analysis encompassing data from approximately 5 years
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