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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Failure (HF) patients | Patients diagnosed with incident HF, in an outpatient setting in Colombia during the time period of 01 JUN 2019 to 31 MAY 2020 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HF medication | Drug | Treatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with incident HF, in an outpatient setting in Colombia during the time period of 01 JUN 2019 to 31 MAY 2020.
The universe of the study corresponds to all individuals who are identified in the database as having HF diagnosed by ICD-10 code in the prescription; the target population corresponds to subjects who were diagnosed and prescribed with a HF treatment at the selected health insurance company and whose prescriptions were filled in Audifarma.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Colombia |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |