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

Both

Age

18 - N/A
  • - Adult patients who have been diagnosed with Heart Failure in a routine clinical practice database in the United States of America.

  • - 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
May 2016 - March 2017
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Primary Outcome

  • Hospitalization
    Proportion of HF patient requiring hospitalization (heart failure related or otherwise)
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Composite of HF-related hospitalization and Mortality
    Proportion 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 years
    enhanced_encryption
    Safety Issue:
    No
  • HF-related burden of illness
    Cox 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 proBNP
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No

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 years
    enhanced_encryption
    Safety Issue:
    No
  • 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 years
    enhanced_encryption
    Safety Issue:
    No
  • Usage and predictors of Long-Acting Nitrates
    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 years
    enhanced_encryption
    Safety Issue:
    No
  • Change in potassium concentration values
    Proportion 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 years
    enhanced_encryption
    Safety Issue:
    No
  • Change in renal function
    Summary 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 years
    enhanced_encryption
    Safety Issue:
    No
  • 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 Days
    Summary 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 values
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • 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 Days
    Summary 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 values
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Treatment Patterns: % of patients Using Angiotensin-Converting Enzyme (ACE) Inhibitors
    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 disease
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • 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 disease
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Treatment Patterns: % of patients Using ACE or 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 values4. HF patients with diabetes 5. HF patients with non-diabetes 6. HF patients with kidney diease 7. HF patients with non-kidney disease
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Treatment Patterns: % of patients Using Beta Blockers
    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 disease
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Treatment Patterns: % of patients Using Calcium Channel Blockers
    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 disease
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Treatment Patterns: % of patients Using Spironolactone
    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 disease
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Treatment Patterns: % of patients Using Eplerenone
    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 disease
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Treatment Patterns: % of patients Using Loop Diuretics
    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 disease
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Treatment Patterns: % of patients Using Long-Acting Nitrates
    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 disease
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Treatment Patterns: % of patients using Vitamin K Antagonist treatment HF medication
    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 disease
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Treatment Patterns: % of patients using Novel Oral Anti-coagulant (NOAC) medication
    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 disease
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Treatment Patterns: % of patients not Using Specified HF Medication
    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 disease
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No
  • 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 disease
    date_rangeTime Frame:
    Retrospective database analysis encompassing data from approximately 5 years
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.