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

NCT05036967 | Completed

• 1 other identifier: 21798
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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

Study Arms (1)

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

Interventions

HF medication DRUG

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

Heart Failure (HF) patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with Acute HF without prior diagnosis of HF

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, Colombia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: September 8, 2021
• Study Start: August 1, 2021
• Primary Completion: November 16, 2022
• Study Completion: November 16, 2022
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)