A Study to Observe Treatment Patterns in Patients in Colombia Who Have Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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HEArt Failure Treatment Patterns: A Descriptive Study in COlombia

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: HF medication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients with Acute HF without prior diagnosis of HF

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart Failure (HF) patients<br>Patients diagnosed with incident HF, in an outpatient setting in Colombia during the time period of 01 JUN 2019 to 31 MAY 2020 | Drug: HF medication<br>* Treatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment initiation patterns | Treatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia. | Database analysis: HF patients from June 1st, 2019 to May 31st, 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: Left ventricular ejection fraction (LVEF) |  | 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 | 
| Subsequent treatment changes | Determination of subsequent treatment changes in HF outpatient. | 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: 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 | 
| 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 |