check_circleStudy Completed
Heart Failure
Bayer Identifier:infoA unique number for a trial given by Bayer.
21798
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
A study to observe treatment patterns in patients in Colombia who have heart failure
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal info
1000The overall number of participants needed for a trial.
Trial Dates info
August 2021 - November 2022Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 4A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
UnspecifiedA “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Recruiting | Many Locations | Many Locations, Colombia |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Treatment initiation patternsTreatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia.date_rangeTime Frame:Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Clinical characteristics at baseline - Symptoms and signs: Dyspneadate_rangeTime Frame:Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
- Clinical characteristics at baseline - Symptoms and signs: Fatiguedate_rangeTime Frame:Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
- Clinical characteristics at baseline - Symptoms and signs: Lower limb edemadate_rangeTime Frame:Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
- Clinical characteristics at baseline - Laboratory data: Hemoglobin and hematocrit leveldate_rangeTime Frame:Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
- Clinical characteristics at baseline - Laboratory data: Left ventricular ejection fraction (LVEF)date_rangeTime Frame:Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
- Clinical characteristics at baseline - Laboratory data: EKG: main findingsdate_rangeTime 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)date_rangeTime Frame:Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
- Clinical characteristics at baseline - Laboratory data: Serum Creatininedate_rangeTime Frame:Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
- Subsequent treatment changesDetermination of subsequent treatment changes in HF outpatient.date_rangeTime 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 BBdate_rangeTime 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 BBdate_rangeTime 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 ARBdate_rangeTime 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 ACEIdate_rangeTime 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 CCBdate_rangeTime 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 MRAdate_rangeTime 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 ARNIdate_rangeTime 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 SGLT2idate_rangeTime Frame:Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
Trial design
Trial Type info
ObservationalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
N/AAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
N/AAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
N/AA “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.