Skip to main content
OpenTrials
Completed

NCT Number: NCT05036967

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HF medication

Drug

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

Primary outcomes

  1. Treatment initiation patterns

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

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

Secondary outcomes

  1. Clinical characteristics at baseline - Symptoms and signs: Dyspnea

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

  2. Clinical characteristics at baseline - Symptoms and signs: Fatigue

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

  3. Clinical characteristics at baseline - Symptoms and signs: Lower limb edema

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

  4. Clinical characteristics at baseline - Laboratory data: Hemoglobin and hematocrit level

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

  5. Clinical characteristics at baseline - Laboratory data: Left ventricular ejection fraction (LVEF)

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

  6. Clinical characteristics at baseline - Laboratory data: EKG: main findings

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

  7. Clinical characteristics at baseline - Laboratory data: Levels of NT-proBNP (N-terminal pro-B-type natriuretic peptide) or BNP (B-type natriuretic peptide)

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

  8. Clinical characteristics at baseline - Laboratory data: Serum Creatinine

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

  9. Subsequent treatment changes

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

    Determination of subsequent treatment changes in HF outpatient.

  10. Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Betablockers BB

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

  11. Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin receptor blockers ARB

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

  12. Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin-converting enzyme inhibitors ACEI

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

  13. Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Calcium-channel blockers CCB

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

  14. Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Mineralocorticoid receptor antagonist MRA

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

  15. Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin receptor-neprilysin inhibitor ARNI

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

  16. Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Sodium-glucose co-transporter 2 inhibitors SGLT2i

    Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

HEArt Failure Treatment Patterns: A Descriptive Study in COlombia

Acronym: HEATCO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 8, 2021
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.