We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT05036967
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05036967
Recruitment Status : Completed
First Posted : September 8, 2021
Last Update Posted : December 15, 2022
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Heart Failure Drug: HF medication

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: HEArt Failure Treatment Patterns: A Descriptive Study in COlombia
Actual Study Start Date : August 1, 2021
Actual Primary Completion Date : November 16, 2022
Actual Study Completion Date : November 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05036967


Locations
Layout table for location information
Colombia
Many Locations
Multiple Locations, Colombia
Sponsors and Collaborators
Bayer
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT05036967    
Other Study ID Numbers: 21798
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: December 15, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases