Trial Condition(s):
Heart Failure
A study to observe treatment patterns in patients in Colombia who have heart failure (HEATCO)
Bayer Identifier:
21798
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, Colombia | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
HEArt failure Treatment patterns: A descriptive study in COlombia
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Treatment initiation patternsTreatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia.Timeframe: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Secondary Outcome
- Clinical characteristics at baseline - Symptoms and signs: DyspneaTimeframe: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
- Clinical characteristics at baseline - Symptoms and signs: FatigueTimeframe: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
- Clinical characteristics at baseline - Symptoms and signs: Lower limb edemaTimeframe: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
- Clinical characteristics at baseline - Laboratory data: Hemoglobin and hematocrit levelTimeframe: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
- Clinical characteristics at baseline - Laboratory data: Left ventricular ejection fraction (LVEF)Timeframe: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
- Clinical characteristics at baseline - Laboratory data: EKG: main findingsTimeframe: 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)Timeframe: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
- Clinical characteristics at baseline - Laboratory data: Serum CreatinineTimeframe: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
- Subsequent treatment changesDetermination of subsequent treatment changes in HF outpatient.Timeframe: 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 BBTimeframe: 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 BBTimeframe: 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 ARBTimeframe: 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 ACEITimeframe: 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 CCBTimeframe: 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 MRATimeframe: 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 ARNITimeframe: 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 SGLT2iTimeframe: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Additional Information
Not Available
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