Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT05350202
Status:
COMPLETED
Last Update Posted:
2025-08-26
First Post:
2022-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Emp-Activity: Empagliflozin Functional Capacity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.', 'description': 'Safety set: All registered patients who gave informed consent and who received empagliflozin at least once.\n\nAs per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Empagliflozin-treated Patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).', 'otherNumAtRisk': 3309, 'deathsNumAtRisk': 3309, 'otherNumAffected': 0, 'seriousNumAtRisk': 3309, 'deathsNumAffected': 46, 'seriousNumAffected': 74}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Coronary artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Escherichia pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Genital haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Implantable defibrillator insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Necrotising fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Necrotising oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Performance status decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vulvovaginal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3309, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin-treated Patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).'}], 'classes': [{'title': 'CSS', 'categories': [{'measurements': [{'value': '14.66', 'spread': '18.44', 'groupId': 'OG000'}]}]}, {'title': 'TSS', 'categories': [{'measurements': [{'value': '17.61', 'spread': '21.04', 'groupId': 'OG000'}]}]}, {'title': 'OSS', 'categories': [{'measurements': [{'value': '16.47', 'spread': '18.86', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and at week 24.', 'description': 'Change from baseline to Week 24 of the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, calculated as \\[Week 24\\] - \\[Baseline\\]. The KCCQ includes 23 items across 7 domains: physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, quality of life, and social limitation. This outcome measured the total symptom score (TTS), clinical summary score (CSS), and overall summary score (OSS) in the empagliflozin-treated patients as defined in the clinical study protocol. The TTS evaluates symptom frequency and burden and is calculated as the mean of the symptom frequency score and symptom burden score. The CSS is calculated as the mean of the physical limitation score and total symptom score. The OSS is calculated as the mean of the physical limitation score, total symptom score, quality of life score, and social limitation score. The TTS, CSS, and OSS are represented on a 0-to-100-point scale, where a higher score reflects better health status.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary endpoint set (PES): All patients, who received at least one dose of empagliflozin for HF and have filled in KCCQ at baseline and week 24.'}, {'type': 'SECONDARY', 'title': 'Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3309', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin-treated Patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).'}], 'classes': [{'title': 'Baseline Class II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1981', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Week 24 Class I', 'measurements': [{'value': '337', 'groupId': 'OG000'}]}, {'title': 'Week 24 Class II', 'measurements': [{'value': '1388', 'groupId': 'OG000'}]}, {'title': 'Week 24 Class III', 'measurements': [{'value': '54', 'groupId': 'OG000'}]}, {'title': 'Week 24 Class IV', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '184', 'groupId': 'OG000'}]}, {'title': 'No Week 24 visit', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Baseline Class III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1263', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Week 24 Class I', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}, {'title': 'Week 24 Class II', 'measurements': [{'value': '730', 'groupId': 'OG000'}]}, {'title': 'Week 24 Class III', 'measurements': [{'value': '368', 'groupId': 'OG000'}]}, {'title': 'Week 24 Class IV', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '118', 'groupId': 'OG000'}]}, {'title': 'No Week 24 visit', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Baseline Class IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Week 24 Class I', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Week 24 Class II', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Week 24 Class III', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Week 24 Class IV', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'No Week 24 visit', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Baseline Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Week 24 Class I', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Week 24 Class II', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Week 24 Class III', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Week 24 Class IV', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No Week 24 visit', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline and at Week 24.', 'description': 'This outcome measured the number of patients newly treated with empagliflozin who experienced a change in the New York Heart Association (NYHA) Class from baseline to Week 24. The NYHA Classes of heart failure categorize patients with symptomatic or advanced heart failure based on their physical activity limitations. Class I patients present no limitation of physical activity, and ordinary physical activity does not cause fatigue, palpitations, or shortness of breath. Class II patients present a slight limitation of physical activity, characterized by fatigue, palpitations, shortness of breath, or chest pain as a result of ordinary physical activity. Class III patients are characterized by a marked limitation of physical activity, where less than ordinary activity causes fatigue, palpitations, shortness of breath, or chest pain. Class IV patients present symptoms of heart failure at rest, where any physical activity causes further discomfort.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set (SAF): All patients of FAS who received empagliflozin at least once.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Comorbidities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3320', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin-treated Patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Non-SGLT2i-treated Patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.'}], 'classes': [{'title': 'E03.- Other hypothyroidism', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'E10.- Insulin-dependent diabetes mellitus', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'E11.- Non-insulin-dependent diabetes mellitus', 'categories': [{'measurements': [{'value': '626', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'E66.- Obesity', 'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'E78.- Disorders of lipoprotein metabolism and other lipidaemias', 'categories': [{'measurements': [{'value': '1197', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'E79.- Disorders of purine and pyrimidine metabolism', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'I10 Essential (primary) hypertension', 'categories': [{'measurements': [{'value': '1380', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'I11.- Hypertensive heart disease', 'categories': [{'measurements': [{'value': '604', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'I20.- Angina pectoris', 'categories': [{'measurements': [{'value': '291', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'I21.- Acute myocardial infarction', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'I25.- Chronic ischaemic heart disease', 'categories': [{'measurements': [{'value': '1164', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'I27.- Other pulmonary heart diseases', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'I34.- Nonrheumatic mitral valve disorders', 'categories': [{'measurements': [{'value': '517', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'I35.- Nonrheumatic aortic valve disorders', 'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'I36.- Nonrheumatic tricuspid valve disorders', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'I42.- Cardiomyopathy', 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'I44.- Atrioventricular and left bundle-branch block', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'I48 Atrial fibrillation and flutter', 'categories': [{'measurements': [{'value': '1183', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'I49.- Other cardiac arrhythmias', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'I70.- Atherosclerosis', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'J44.- Other chronic obstructive pulmonary disease', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'N18.- Chronic kidney disease', 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'N40 Hyperplasia of prostate', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Z95.- Presence of cardiac and vascular implants and grafts', 'categories': [{'measurements': [{'value': '547', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline.', 'description': 'Number of patients with first prescription of empagliflozin and patients prescribed drugs other than SGLT2 inhibitors with concomitant disease/comorbidities. Concomitant diseases/comorbidities are presented according to the ICD-10-CM (the International Classification of Diseases, Tenth Revision, Clinical Modification) standardized system using the disease code.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: All registered patients who gave informed consent.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Concomitant Heart-failure (HF) Related Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3320', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin-treated Patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Non-SGLT2i-treated Patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.'}], 'classes': [{'title': 'Acetylsalicylic acid', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Bisoprolol', 'categories': [{'measurements': [{'value': '868', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Candesartan', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Carvedilol', 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Eplerenone', 'categories': [{'measurements': [{'value': '517', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Furosemide', 'categories': [{'measurements': [{'value': '913', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Indapamide', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Metoprolol', 'categories': [{'measurements': [{'value': '457', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Nebivolol', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Perindopril', 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Ramipril', 'categories': [{'measurements': [{'value': '413', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Sacubitril', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sacubitril and valsartan', 'categories': [{'measurements': [{'value': '443', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Spironolactone', 'categories': [{'measurements': [{'value': '981', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Torasemide', 'categories': [{'measurements': [{'value': '645', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Valsartan', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline.', 'description': 'Number of patients who took concomitant HF-related medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: All registered patients who gave informed consent.'}, {'type': 'SECONDARY', 'title': 'Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3320', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin-treated Patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).'}, {'id': 'OG001', 'title': 'Non-SGLT2i-treated Patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.'}], 'classes': [{'categories': [{'measurements': [{'value': '284', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 months prior to baseline visit.', 'description': 'Number of patients hospitalized at least one time due to heart failure (HF).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: All registered patients who gave informed consent.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Empagliflozin-treated Patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).'}, {'id': 'FG001', 'title': 'Non-SGLT2i-treated Patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.'}], 'periods': [{'title': 'Visit 1 - Baseline', 'milestones': [{'type': 'STARTED', 'comment': 'Patients recruited', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3327'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3320'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'Treated', 'comment': 'Receiving a drug prescription', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3309'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3309'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Not-treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Visit 1 to Visit 2 - 24 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3309'}, {'comment': 'Non-SGLT2i-treated patients were not followed past Visit 1.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3152'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Still active/screening failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other reason than listed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse-drug reaction/heart failure hospitalization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A multinational, non-interventional study based on newly collected data to assess the demographics and treatment patterns of patients with heart failure (HF), with or without diabetes, using a two-cohort design: one cohort included patients with a first prescription of empagliflozin as routine therapy for HF, while the other cohort included patients receiving drugs with a mechanism of action different from empagliflozin.', 'preAssignmentDetails': 'All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that they (the participants) strictly met all inclusion and none of the exclusion criteria. Participants were not to be allocated to a group if any of the entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3320', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '3424', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Empagliflozin-treated Patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).'}, {'id': 'BG001', 'title': 'Non-SGLT2i-treated Patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3320', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '3424', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '69.63', 'spread': '10.52', 'groupId': 'BG000'}, {'value': '79.67', 'spread': '10.56', 'groupId': 'BG001'}, {'value': '69.67', 'spread': '10.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3320', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '3424', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1224', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '1271', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2096', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '2153', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'classes': [{'title': 'CSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3314', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '3417', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61.64', 'spread': '22.45', 'groupId': 'BG000'}, {'value': '67.23', 'spread': '17.90', 'groupId': 'BG001'}, {'value': '61.81', 'spread': '22.35', 'groupId': 'BG002'}]}]}, {'title': 'TSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3314', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '3417', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59.03', 'spread': '24.86', 'groupId': 'BG000'}, {'value': '66.13', 'spread': '20.57', 'groupId': 'BG001'}, {'value': '59.25', 'spread': '24.76', 'groupId': 'BG002'}]}]}, {'title': 'OSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3314', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '3417', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56.29', 'spread': '22.73', 'groupId': 'BG000'}, {'value': '61.46', 'spread': '20.21', 'groupId': 'BG001'}, {'value': '56.45', 'spread': '22.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The KCCQ includes 23 items across 7 domains: physical limitation, symptom stability, symptom frequency and burden, self-efficacy, quality of life, and social limitation. The total symptom score (TTS) is calculated as the mean of the symptom-related scores. The clinical summary score (CSS) is calculated as the mean of the physical limitation and total symptom score. The overall symptom score (OSS) is calculated as the mean of the physical limitation, total symptom, quality of life, and social limitation score. All scores range from 0 to 100, with higher scores indicating better health.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set: all registered patients who gave informed consent. Patients without baseline KCCQ values were excluded.'}], 'populationDescription': 'Full analysis set: all registered patients who gave informed consent.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-30', 'size': 387687, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-09T07:25', 'hasProtocol': True}, {'date': '2023-11-02', 'size': 319777, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-09T07:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3431}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2022-04-22', 'resultsFirstSubmitDate': '2025-07-16', 'studyFirstSubmitQcDate': '2022-04-22', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-21', 'studyFirstPostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice', 'timeFrame': 'At baseline and at week 24.', 'description': 'Change from baseline to Week 24 of the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, calculated as \\[Week 24\\] - \\[Baseline\\]. The KCCQ includes 23 items across 7 domains: physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, quality of life, and social limitation. This outcome measured the total symptom score (TTS), clinical summary score (CSS), and overall summary score (OSS) in the empagliflozin-treated patients as defined in the clinical study protocol. The TTS evaluates symptom frequency and burden and is calculated as the mean of the symptom frequency score and symptom burden score. The CSS is calculated as the mean of the physical limitation score and total symptom score. The OSS is calculated as the mean of the physical limitation score, total symptom score, quality of life score, and social limitation score. The TTS, CSS, and OSS are represented on a 0-to-100-point scale, where a higher score reflects better health status.'}], 'secondaryOutcomes': [{'measure': 'Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin', 'timeFrame': 'At baseline and at Week 24.', 'description': 'This outcome measured the number of patients newly treated with empagliflozin who experienced a change in the New York Heart Association (NYHA) Class from baseline to Week 24. The NYHA Classes of heart failure categorize patients with symptomatic or advanced heart failure based on their physical activity limitations. Class I patients present no limitation of physical activity, and ordinary physical activity does not cause fatigue, palpitations, or shortness of breath. Class II patients present a slight limitation of physical activity, characterized by fatigue, palpitations, shortness of breath, or chest pain as a result of ordinary physical activity. Class III patients are characterized by a marked limitation of physical activity, where less than ordinary activity causes fatigue, palpitations, shortness of breath, or chest pain. Class IV patients present symptoms of heart failure at rest, where any physical activity causes further discomfort.'}, {'measure': 'Number of Participants With Comorbidities', 'timeFrame': 'At baseline.', 'description': 'Number of patients with first prescription of empagliflozin and patients prescribed drugs other than SGLT2 inhibitors with concomitant disease/comorbidities. Concomitant diseases/comorbidities are presented according to the ICD-10-CM (the International Classification of Diseases, Tenth Revision, Clinical Modification) standardized system using the disease code.'}, {'measure': 'Number of Participants With Concomitant Heart-failure (HF) Related Medication', 'timeFrame': 'At baseline.', 'description': 'Number of patients who took concomitant HF-related medication.'}, {'measure': 'Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline', 'timeFrame': 'Up to 6 months prior to baseline visit.', 'description': 'Number of patients hospitalized at least one time due to heart failure (HF).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a multinational non-interventional study based on newly collected data to assess demographics, disease, and treatment pattern of patients with chronic Heart Failure (HF) in a two-cohort design: one cohort will receive first prescription of empagliflozin as routine therapy for HF, the other cohort will receive HF therapy with drugs with another mechanism of action. Treatment of HF according to routine practice is determined by the physician independent of the participation of the patient in this non-interventional study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic Heart Failure (HF) in a two cohort design: one cohort will receive first prescription of empagliflozin as routine therapy for HF, the other cohort will receive HF therapy with drugs with another mechanism of action.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent prior to study participation\n* Male and female patients ≥ 18 years at Visit 1\n* Patients must be contractually capable and mentally able to understand and follow the instructions of the study personnel\n* Patients with diagnosis of chronic heart failure NYHA Class 2-4\n* Treatment-naïve for SGLT2i at visit 1\n* Women of childbearing potential must take appropriate precautions against getting pregnant according to approval of chosen HF drug(s)\n\nExclusion Criteria:\n\n* Missing physician's diagnosis of chronic heart failure\n* Patients hospitalized at visit 1\n* Life expectancy ≤ 12 months according to physician's assessment\n* Lack of informed consent\n* Pregnant or lactating females\n* Participation in a parallel interventional clinical trial\n* Chosen treatment with another SGLT2i drug than empagliflozin\n* Having been enrolled into the non-empagliflozin-arm of this non-interventional study\n* Current or prior treatment with SGLT2i at visit 1\n* Patients with contraindications according to current Summary of Product Characteristics (SmPC)\n* Patients with dependency or relationship to the treating physician"}, 'identificationModule': {'nctId': 'NCT05350202', 'briefTitle': 'Emp-Activity: Empagliflozin Functional Capacity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Empagliflozin Functional Capacity - Non-Interventional Study', 'orgStudyIdInfo': {'id': '1245-0259'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Empagliflozin-treated patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).', 'interventionNames': ['Drug: Empagliflozin']}, {'label': 'Non-SGLT2i-treated patients', 'description': 'Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.'}], 'interventions': [{'name': 'Empagliflozin', 'type': 'DRUG', 'otherNames': ['Jardiance®'], 'description': 'Empagliflozin was administered according to the approved product information.', 'armGroupLabels': ['Empagliflozin-treated patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Burgas', 'country': 'Bulgaria', 'facility': 'Dr. Mircheva', 'geoPoint': {'lat': 42.50651, 'lon': 27.46886}}, {'zip': '6304', 'city': 'Haskovo', 'country': 'Bulgaria', 'facility': 'Dr. Yordanov', 'geoPoint': {'lat': 41.93415, 'lon': 25.55557}}, {'zip': '6600', 'city': 'Kardzhali', 'country': 'Bulgaria', 'facility': 'MBAL Atanas Dafovski, Kardzhali', 'geoPoint': {'lat': 41.64502, 'lon': 25.36578}}, {'zip': '2501', 'city': 'Kyustendil', 'country': 'Bulgaria', 'facility': 'Dr. Krasteva', 'geoPoint': {'lat': 42.28314, 'lon': 22.69224}}, {'zip': '5500', 'city': 'Lovech', 'country': 'Bulgaria', 'facility': 'Dr. Todorov', 'geoPoint': {'lat': 43.13227, 'lon': 24.71763}}, {'zip': '5500', 'city': 'Lovech', 'country': 'Bulgaria', 'facility': 'Dr. Tsoneva', 'geoPoint': {'lat': 43.13227, 'lon': 24.71763}}, {'zip': '4270', 'city': 'Parvomay', 'country': 'Bulgaria', 'facility': 'Dr. Pavlov', 'geoPoint': {'lat': 42.1, 'lon': 25.21667}}, {'zip': '4400', 'city': 'Pazardzhik', 'country': 'Bulgaria', 'facility': 'Medical Center, Pazardjik', 'geoPoint': {'lat': 42.19934, 'lon': 24.33318}}, {'zip': '2300', 'city': 'Pernik', 'country': 'Bulgaria', 'facility': 'Dr. Stankova', 'geoPoint': {'lat': 42.59671, 'lon': 23.03318}}, {'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'assoc.prof. Gospodinov', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'dr. Kostadinovska', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'prof.Tisheva', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '4001', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Dr. Mekenian', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Dr. Ilchev', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '4018', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Dr. Hairabedian', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '4020', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Dr. Filipov', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '8800', 'city': 'Sliven', 'country': 'Bulgaria', 'facility': 'MBAL Sliven, Dr. Bletsova', 'geoPoint': {'lat': 42.68607, 'lon': 26.32558}}, {'zip': '1000', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Dr. Pancheva', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1000', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'prof. Velchev', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1202', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'dr. Georgieva', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1202', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'dr. Karchinova', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1202', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'prof.Vitlianova', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1233', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'dr. Petrusheva', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1407', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'dr. 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