Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-27 @ 1:33 PM
Study NCT ID:
NCT05036967
Status:
COMPLETED
Last Update Posted:
2022-12-15
First Post:
2021-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Observe Treatment Patterns in Patients in Colombia Who Have Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-14', 'studyFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-08-31', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment initiation patterns', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020', 'description': 'Treatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia.'}], 'secondaryOutcomes': [{'measure': 'Clinical characteristics at baseline - Symptoms and signs: Dyspnea', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020'}, {'measure': 'Clinical characteristics at baseline - Symptoms and signs: Fatigue', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020'}, {'measure': 'Clinical characteristics at baseline - Symptoms and signs: Lower limb edema', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020'}, {'measure': 'Clinical characteristics at baseline - Laboratory data: Hemoglobin and hematocrit level', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020'}, {'measure': 'Clinical characteristics at baseline - Laboratory data: Left ventricular ejection fraction (LVEF)', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020'}, {'measure': 'Clinical characteristics at baseline - Laboratory data: EKG: main findings', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020'}, {'measure': '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'}, {'measure': 'Clinical characteristics at baseline - Laboratory data: Serum Creatinine', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020'}, {'measure': 'Subsequent treatment changes', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020', 'description': 'Determination of subsequent treatment changes in HF outpatient.'}, {'measure': 'Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Betablockers BB', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020'}, {'measure': 'Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin receptor blockers ARB', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020'}, {'measure': 'Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin-converting enzyme inhibitors ACEI', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020'}, {'measure': 'Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Calcium-channel blockers CCB', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020'}, {'measure': 'Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Mineralocorticoid receptor antagonist MRA', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020'}, {'measure': 'Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin receptor-neprilysin inhibitor ARNI', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020'}, {'measure': 'Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Sodium-glucose co-transporter 2 inhibitors SGLT2i', 'timeFrame': 'Database analysis: HF patients from June 1st, 2019 to May 31st, 2020'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': "Researchers want to learn more about the treatments doctors choose to treat heart failure.\n\nHeart 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.\n\nThere 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.\n\nThe 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.\n\nThe study will include adult patients who have been diagnosed with heart failure in Columbia from June 1st, 2019 to May 31st, 2020.\n\nThere 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with incident HF, in an outpatient setting in Colombia during the time period of 01 JUN 2019 to 31 MAY 2020.\n\nThe 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Patients with Acute HF without prior diagnosis of HF'}, 'identificationModule': {'nctId': 'NCT05036967', 'acronym': 'HEATCO', 'briefTitle': 'A Study to Observe Treatment Patterns in Patients in Colombia Who Have Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'HEArt Failure Treatment Patterns: A Descriptive Study in COlombia', 'orgStudyIdInfo': {'id': '21798'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heart Failure (HF) patients', 'description': 'Patients diagnosed with incident HF, in an outpatient setting in Colombia during the time period of 01 JUN 2019 to 31 MAY 2020', 'interventionNames': ['Drug: HF medication']}], 'interventions': [{'name': 'HF medication', 'type': 'DRUG', 'description': 'Treatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia.', 'armGroupLabels': ['Heart Failure (HF) patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Colombia', 'facility': 'Many Locations'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}