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

Heart Failure Clinical Trial

— HEATCO  

Official title:

HEArt Failure Treatment Patterns: A Descriptive Study in COlombia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05036967
• Other study ID #: 21798
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: November 16, 2022

Study information

• Verified date: December 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: November 16, 2022
• Est. primary completion date: November 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• HF medication
Treatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia.

Locations

Country	Name	City	State
Colombia	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical characteristics at baseline - Symptoms and signs: Dyspnea		Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Secondary	Clinical characteristics at baseline - Symptoms and signs: Fatigue		Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Secondary	Clinical characteristics at baseline - Symptoms and signs: Lower limb edema		Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Secondary	Clinical characteristics at baseline - Laboratory data: Hemoglobin and hematocrit level		Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Secondary	Clinical characteristics at baseline - Laboratory data: Left ventricular ejection fraction (LVEF)		Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Secondary	Clinical characteristics at baseline - Laboratory data: EKG: main findings		Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Secondary	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
Secondary	Clinical characteristics at baseline - Laboratory data: Serum Creatinine		Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Secondary	Subsequent treatment changes	Determination of subsequent treatment changes in HF outpatient.	Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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