Heart FailureHEATCONCT05036967
A Study to Observe Treatment Patterns in Patients in Colombia Who Have Heart Failure
An observational study of Heart Failure, run by Bayer at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- HF medication
- How many people
- 1,000 participants
- Where
- 1 siteColombia
- Study dates
- 1 Aug 2021to 16 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients with Acute HF without prior diagnosis of HF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- HF medication
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF medicationDrug
Treatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: HF medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment initiation patterns
Treatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia.
Measured: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Secondary outcomes (16)
Clinical characteristics at baseline - Symptoms and signs: Dyspnea
Measured: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Symptoms and signs: Fatigue
Measured: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Symptoms and signs: Lower limb edema
Measured: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Laboratory data: Hemoglobin and hematocrit level
Measured: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Laboratory data: Left ventricular ejection fraction (LVEF)
Measured: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Laboratory data: EKG: main findings
Measured: 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)
Measured: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Laboratory data: Serum Creatinine
Measured: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Subsequent treatment changes
Determination of subsequent treatment changes in HF outpatient.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start1 Aug 2021
- Primary completion16 Nov 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036967
- Sponsor's protocol ID
- 21798
- Acronym
- HEATCO
- Status last verified
- Dec 2022
- First submitted
- 19 Jul 2021
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEArt Failure Treatment Patterns: A Descriptive Study in COlombia
- ClinicalTrials.gov ID
- NCT05036967
- Acronym / sponsor ID
- HEATCO / 21798
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure (HF) patients | – | Drug: HF medicationPatients diagnosed with incident HF, in an outpatient setting in Colombia during the time period of 01 JUN 2019 to 31 MAY 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with Acute HF without prior diagnosis of HF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HF medicationTreatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia. | Drug | Heart Failure (HF) patients |
Primary outcome
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.
16 secondary outcomes
Clinical characteristics at baseline - Symptoms and signs: Dyspnea
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Symptoms and signs: Fatigue
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Symptoms and signs: Lower limb edema
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Laboratory data: Hemoglobin and hematocrit level
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
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
Clinical characteristics at baseline - Laboratory data: EKG: main findings
Time frame: 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)
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Clinical characteristics at baseline - Laboratory data: Serum Creatinine
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Subsequent treatment changes
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: No. 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.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Bayer at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment initiation patterns (time frame: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.