Clinical trial NCT05036967: A Study to Observe Treatment Patterns in Patients in Colombia Who Have Heart Failure
Official title: HEArt Failure Treatment Patterns: A Descriptive Study in COlombia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-09-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment initiation patterns
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Secondary outcomes:
measure: Clinical characteristics at baseline - Symptoms and signs: Dyspnea
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Clinical characteristics at baseline - Symptoms and signs: Fatigue
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Clinical characteristics at baseline - Symptoms and signs: Lower limb edema
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Clinical characteristics at baseline - Laboratory data: Hemoglobin and hematocrit level
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Clinical characteristics at baseline - Laboratory data: Left ventricular ejection fraction (LVEF)
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Clinical characteristics at baseline - Laboratory data: EKG: main findings
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Clinical characteristics at baseline - Laboratory data: Levels of NT-proBNP (N-terminal pro-B-type natriuretic peptide) or BNP (B-type natriuretic peptide)
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Clinical characteristics at baseline - Laboratory data: Serum Creatinine
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Subsequent treatment changes
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Betablockers BB
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin receptor blockers ARB
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin-converting enzyme inhibitors ACEI
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Calcium-channel blockers CCB
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Mineralocorticoid receptor antagonist MRA
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin receptor-neprilysin inhibitor ARNI
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
measure: Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Sodium-glucose co-transporter 2 inhibitors SGLT2i
timeFrame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Other outcomes:
Locations:
city: Multiple Locations
country: Colombia
facility: Many Locations
Study officials:
References: