Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-01-16 @ 2:46 PM
Study NCT ID:
NCT06707220
Status:
RECRUITING
Last Update Posted:
2025-03-03
First Post:
2024-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Türkiye Heart Failure Registry
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2024-11-24', 'studyFirstSubmitQcDate': '2024-11-24', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart failure hospitalization', 'timeFrame': 'From enrollment to the end of follow-up period at 12 months'}, {'measure': 'Cardiovascular mortality', 'timeFrame': 'From enrollment to the end of follow-up period at 12 months'}, {'measure': 'Composite of heart failure hospitalization and cardiovascular mortality', 'timeFrame': 'From enrollment to the end of follow-up period at 12 months'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'From enrollment to the end of follow-up period at 12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '39340234', 'type': 'BACKGROUND', 'citation': 'Kocabas U, Ergin I, Yavuz V, Altin C, Kaplan M, Yilmaz Oztekin GM, Dogdus M, Murat S, Murat B, Kivrak T, Karabulut D, Kaya E, Ozdemir IH, Yildiz C, Salkin FO, Ozcalik E, Polatkan SG, Cakan F, Sen T, Karabulut U, Cakal S, Oflar E, Sinan UY, Yenercag M, Turk UO. Real-world data on Empagliflozin and Dapagliflozin use in patients with HEART failure: The RED-HEART study. ESC Heart Fail. 2025 Feb;12(1):434-446. doi: 10.1002/ehf2.15049. Epub 2024 Sep 28.'}, {'pmid': '37804042', 'type': 'BACKGROUND', 'citation': 'Kocabas U, Ergin I, Kivrak T, Yilmaz Oztekin GM, Tanik VO, Ozdemir I, Avci Demir F, Dogdus M, Sen T, Altinsoy M, Ustundag S, Urgun OD, Sinan UY, Uygur B, Yeni M, Ozcalik E. Prognostic significance of medical therapy in patients with heart failure with reduced ejection fraction. ESC Heart Fail. 2023 Dec;10(6):3677-3689. doi: 10.1002/ehf2.14559. Epub 2023 Oct 7.'}, {'pmid': '32628147', 'type': 'BACKGROUND', 'citation': 'Kocabas U, Kivrak T, Yilmaz Oztekin GM, Tanik VO, Ozdemir IH, Kaya E, Yuce EI, Avci Demir F, Dogdus M, Altinsoy M, Ustundag S, Ozyurtlu F, Karagoz U, Karakus A, Urgun OD, Sinan UY, Mutlu I, Sen T, Astarcioglu MA, Kinik M, Tok OO, Uygur B, Yeni M, Alan B, Dalgic O, Sariturk C, Altay H, Pehlivanoglu S. Adherence to guideline-directed medical and device Therapy in outpAtients with heart failure with reduced ejection fraction: The ATA study. Anatol J Cardiol. 2020 Jul;24(1):32-40. doi: 10.14744/AnatolJCardiol.2020.91771.'}]}, 'descriptionModule': {'briefSummary': 'A comprehensive understanding of the socio-demographic, clinical, and biological characteristics of patients with heart failure is essential to develop novel strategies for improving outcomes. The identification of the barriers to guideline-directed medical therapy implementation in a real-world setting is critical to decreasing the risk of heart failure hospitalization and mortality. A comprehensive and well-designed heart failure registry can determine the clinical characteristics of patients with heart failure, identify patient, physician, and healthcare system-related factors for the non-use of evidence-based therapies, and improve the implementation of guideline-directed medical therapy. It should be noted that the number of heart failure registries that enroll patients with de novo heart failure, chronic heart failure (outpatients), and worsening of heart failure (hospitalized or treated in the emergency department), with all three relevant ejection fraction categories (heart failure with reduced ejection fraction, heart failure with mildly-reduced ejection fraction, and heart failure with preserved ejection fraction), is limited. Furthermore, only a few registries assess detailed aspects of guideline adherence, treatment decisions, and both in-hospital and long-term outcomes. Therefore, the Türkiye Heart Failure (TURK-HF) registry has been designed to address this gap in knowledge about the identification, management, and long-term prognosis of patients with heart failure in a real-world setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The only inclusion criterion for the Türkiye Heart Failure (TURK-HF) registry is the presence of heart failure, as determined by an investigator, and the only exclusion criterion is age \\<18 years. All patients will be eligible for enrollment regardless of their ejection fraction and whether they have pre-existing chronic or de novo heart failure. All patients will be enrolled in the study, regardless of their clinical status. This encompasses both those presenting for a non-urgent outpatient visit with stable signs and symptoms and those requiring urgent care with worsening of heart failure. Worsening heart failure is defined as worsening symptoms and signs of heart failure in patients with pre-existing heart failure, requiring hospitalization and/or intravenous diuretic therapy. All study participants must provide written informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Presence of heart failure -\n\nExclusion Criteria: Age \\<18 years\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06707220', 'acronym': 'TURK-HF', 'briefTitle': 'The Türkiye Heart Failure Registry', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'The Türkiye Heart Failure (TURK-HF) Registry', 'orgStudyIdInfo': {'id': 'KA23/429'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Heart failure medication', 'type': 'OTHER', 'description': 'Treated with optimal guideline-directed medical therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0600', 'city': 'Ankara', 'state': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Umut Kocabaş, M.D.', 'role': 'CONTACT', 'email': 'umutkocabas@hotmail.com', 'phone': '+905079974999'}], 'facility': 'Baskent University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Umut Kocabaş', 'role': 'CONTACT', 'email': 'umutkocabas@hotmail.com', 'phone': '+905079974999'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Umut Kocabas', 'investigatorAffiliation': 'Baskent University'}}}}