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

HEArt Failure Treatment Patterns: A Descriptive Study in COlombia

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: HF medication

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Colombia
  • Multiple Locations, Colombia
    • Many locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: HF medication; Treatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): November 16, 2022
• Study Completion (Actual): November 16, 2022

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 21798

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.