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

Sponsor
Bayer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05036967
Collaborator
(none)
11,598
1
14
828.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: HF medication

Study Design

Study Type:
Observational
Anticipated Enrollment :
11598 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
HEArt Failure Treatment Patterns: A Descriptive Study in COlombia
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Treatment initiation patterns [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 Outcome Measures

  1. Clinical characteristics at baseline - Symptoms and signs: Dyspnea [Database analysis: HF patients from June 1st, 2019 to May 31st, 2020]

  2. Clinical characteristics at baseline - Symptoms and signs: Fatigue [Database analysis: HF patients from June 1st, 2019 to May 31st, 2020]

  3. Clinical characteristics at baseline - Symptoms and signs: Lower limb edema [Database analysis: HF patients from June 1st, 2019 to May 31st, 2020]

  4. Clinical characteristics at baseline - Laboratory data: Hemoglobin and hematocrit level [Database analysis: HF patients from June 1st, 2019 to May 31st, 2020]

  5. Clinical characteristics at baseline - Laboratory data: Left ventricular ejection fraction (LVEF) [Database analysis: HF patients from June 1st, 2019 to May 31st, 2020]

  6. Clinical characteristics at baseline - Laboratory data: EKG: main findings [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) [Database analysis: HF patients from June 1st, 2019 to May 31st, 2020]

  8. Clinical characteristics at baseline - Laboratory data: Serum Creatinine [Database analysis: HF patients from June 1st, 2019 to May 31st, 2020]

  9. Subsequent treatment changes [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 [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 [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 [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 [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 [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 [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 [Database analysis: HF patients from June 1st, 2019 to May 31st, 2020]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Many Locations Multiple Locations Colombia

Sponsors and Collaborators

  • Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT05036967
Other Study ID Numbers:
  • 21798
First Posted:
Sep 8, 2021
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022