A Study to Observe Treatment Patterns in Patients in Colombia Who Have Heart Failure
- Conditions
- Heart Failure
- Interventions
- Drug: HF medication
- Registration Number
- NCT05036967
- Lead Sponsor
- Bayer
- Brief Summary
Researchers want to learn more about the treatments doctors choose to treat heart failure.
Heart failure means the heart isn't pumping as well as it should be. Heart failure can lead to other serious medical conditions, and it can lead to hospitalization or death.
There are different types of treatments available for people who have heart failure, and these work in different ways. In this study, the researchers will collect information about Colombian patients who have heart failure.
The main purpose of this study is to identify patterns in the treatments that doctors first prescribe to heart failure patients in Columbia. To do this, the researchers will review information from the patients' medical records and from a drug-dispensing database.
The study will include adult patients who have been diagnosed with heart failure in Columbia from June 1st, 2019 to May 31st, 2020.
There will be no required visits, treatments, or procedures in this study. The researchers will collect information about the treatments the patients have been prescribed by their own doctors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
- Adult patients (older than 18 years) with a diagnosis of HF according to ICD-10 with a dispensing of some medicine and it is registered in the database of Audifarma S.A. during the observation period will be included
- Patients with Acute HF without prior diagnosis of HF
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Heart Failure (HF) patients HF medication Patients diagnosed with incident HF, in an outpatient setting in Colombia during the time period of 01 JUN 2019 to 31 MAY 2020
- Primary Outcome Measures
Name Time Method Treatment initiation patterns Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Treatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia.
- Secondary Outcome Measures
Name Time Method Clinical characteristics at baseline - Laboratory data: Left ventricular ejection fraction (LVEF) Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Clinical characteristics at baseline - Symptoms and signs: Dyspnea Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Clinical characteristics at baseline - Symptoms and signs: Fatigue Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Clinical characteristics at baseline - Symptoms and signs: Lower limb edema Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Clinical characteristics at baseline - Laboratory data: Hemoglobin and hematocrit level Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Clinical characteristics at baseline - Laboratory data: EKG: main findings Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Clinical characteristics at baseline - Laboratory data: Levels of NT-proBNP (N-terminal pro-B-type natriuretic peptide) or BNP (B-type natriuretic peptide) Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Clinical characteristics at baseline - Laboratory data: Serum Creatinine Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Sodium-glucose co-transporter 2 inhibitors SGLT2i Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Subsequent treatment changes Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Determination of subsequent treatment changes in HF outpatient.
Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Betablockers BB Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin receptor blockers ARB Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin-converting enzyme inhibitors ACEI Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Calcium-channel blockers CCB Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Mineralocorticoid receptor antagonist MRA Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin receptor-neprilysin inhibitor ARNI Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Trial Locations
- Locations (1)
Many Locations
🇨🇴Multiple Locations, Colombia