check_circleStudy Completed

Heart Failure

Bayer Identifier:

21798

ClinicalTrials.gov Identifier:

NCT05036967

EudraCT Number:

Not Available

EU CT Number:

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - Patients with Acute HF without prior diagnosis of HF

Trial summary

Enrollment Goal
1000
Trial Dates
August 2021 - November 2022
Phase
Phase 4
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many LocationsMany Locations, Colombia

Primary Outcome

  • Treatment initiation patterns
    Treatment 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 Outcome

  • Clinical characteristics at baseline - Symptoms and signs: Dyspnea
    date_rangeTime Frame:
    Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
  • Clinical characteristics at baseline - Symptoms and signs: Fatigue
    date_rangeTime Frame:
    Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
  • Clinical characteristics at baseline - Symptoms and signs: Lower limb edema
    date_rangeTime Frame:
    Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
  • Clinical characteristics at baseline - Laboratory data: Hemoglobin and hematocrit level
    date_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 findings
    date_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 Creatinine
    date_rangeTime Frame:
    Database analysis: HF patients from June 1st, 2019 to May 31st, 2020
  • Subsequent treatment changes
    Determination 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 BB
    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 BB
    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: Angiotensin receptor blockers ARB
    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: Angiotensin-converting enzyme inhibitors ACEI
    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: Calcium-channel blockers CCB
    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: Mineralocorticoid receptor antagonist MRA
    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: Angiotensin receptor-neprilysin inhibitor ARNI
    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: Sodium-glucose co-transporter 2 inhibitors SGLT2i
    date_rangeTime Frame:
    Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

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
N/A