Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT07154758
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Registry BAsed Optimization Of Therapy in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-08-15', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants referred for physiotherapy in the interventional vs. control arm.', 'timeFrame': 'End of implementation for the screening arm; 1-year from index date for the control arm', 'description': 'Referral for physiotherapy (Yes/No) in the interventional vs. control arm.'}], 'primaryOutcomes': [{'measure': 'Number of participants experiencing at least one event of treatment optimization', 'timeFrame': 'End of implementation for the screening arm; 1-year from index date for the control arm', 'description': 'Number of participants experiencing at least one of the following:\n\n1. Drug initiation or uptitration (SGLT2i, MRA, BB, RASi, ARNi, iv iron)\n2. ID screening\n3. Initiation/planning for device CRT/ICD Outcome measured as variable yes/no'}], 'secondaryOutcomes': [{'measure': 'Number of participants experiencing at least one drug initiation in the interventional vs. control arm.', 'timeFrame': 'End of implementation for the screening arm; 1-year from index date for the control arm', 'description': 'Number of participants experiencing at least one drug initiation (SGLT2i, MRA, RASi or ARNi, BB, iv iron) in the interventional vs. control arm.'}, {'measure': 'Number of participants experiencing at least one drug dose up-titration in the interventional vs. control arm.', 'timeFrame': 'End of implementation for the screening arm; 1-year from index date for the control arm', 'description': 'Number of participants experiencing at least one drug dose up-titration (MRA, RASi or ARNi, BB) in the interventional vs. control arm.'}, {'measure': 'Number of participants experiencing referral for CRT or ICD in the interventional vs. control arm.', 'timeFrame': 'End of implementation for the screening arm; 1-year from index date for the control arm', 'description': 'Number of patients referred for ICD/CRT in the interventional vs. control arm.'}, {'measure': 'Number of participants screened for iron deficiency in the interventional vs. control arm.', 'timeFrame': 'End of implementation for the screening arm; 1-year from index date for the control arm', 'description': 'Number of patients screened for ID in the interventional vs. control arm.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Implementation', 'Guideline-directed medical therapy', 'registry', 'Swedish Heart Failure Registry'], 'conditions': ['Heart Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ucr.uu.se/rikssvikt-en/', 'label': 'Swedish Heart Failure Registry webpage'}]}, 'descriptionModule': {'briefSummary': 'Rationale. Although several pharmacological treatments, namely renin-angiotensin-system inhibitors, sacubitril/valsartan, beta-blockers, mineralocorticoid receptor antagonists and sodium-glucose cotransporter-2 inhibitors, improve mortality/morbidity in heart failure with reduced ejection fraction (HFrEF), their use in clinical practice is still limited.\n\nAim. The aim of this project is to use the Swedish HF registry to identify HFrEF patients in need of 1) treatment implementation (initiation of treatments/uptitration), 2) screening and treatment of ID, and 3) with an indication for HF devices (CRT or ICD) but not implanted device, 4) referral for physiotherapy.\n\nOutcomes.\n\nPrimary outcome: number of participants experiencing at least one of the following:\n\n1. Drug initiation or uptitration (SGLT2i, MRA, BB, RASi, ARNi, iv iron)\n2. ID screening\n3. Referral for device therapy (CRT/ICD)\n\nSecondary outcome:\n\n1. Number of participants experiencing at least one drug initiation in the interventional vs. control arm.\n2. Number of participants experiencing at least one drug dose up-titration in the interventional vs. control arm.\n3. Number of participants experiencing referral for CRT or ICD in the interventional vs. control arm.\n4. Number of participants screened for iron deficiency in the interventional vs. control arm.\n\nTertiary outcome:\n\n1\\. Number of participants referred for physiotherapy in the interventional vs. control arm.\n\nStudy design. 500 patients will be screened through the Swedish Heart Failure Registry and, whether not on optimal medical treatment, implementation will be started. Outcome will be compared with a control population of 500 patients not enrolled in SwedeHF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Registration in SwedeHF with an index date after January 1st 2023 for the screening arm. For controls, hospital access after January 1st 2023.\n* HF duration \\>6 months to ensure that patients had time to go through the treatment optimization process as recommended by the guidelines.\n* HF with reduced EF (HFrEF) defined as categorical or continuous EF ≤40%\n* Capable of giving signed informed consent (for the screening arm)\n\nExclusion Criteria:\n\n* Under optimization of HF therapy\n* In judgment of the investigator unlikely to understand or comply with study procedures\n\nControl population is sex and age matched with the SwedeHF screening arm (1:1)'}, 'identificationModule': {'nctId': 'NCT07154758', 'acronym': 'REBOOT-HFrEF', 'briefTitle': 'Registry BAsed Optimization Of Therapy in Heart Failure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Stockholm'}, 'officialTitle': 'Optimizing HF Treatment by Registry Screening for Need of Implementation and Referral to the Optimization Outpatient Clinic', 'orgStudyIdInfo': {'id': '2023-04364-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening through SwedeHF', 'description': 'HFrEF patients enrolled in SwedeHF and screened for need of GDMT implementation through SwedeHF', 'interventionNames': ['Other: Screening for need of HFrEF GDMT implementation through SwedeHF']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'HFrEF patients not enrolled in the SwedeHF and therefore not undergoing screening for GDMT implementation'}], 'interventions': [{'name': 'Screening for need of HFrEF GDMT implementation through SwedeHF', 'type': 'OTHER', 'description': 'Screening for need of HFrEF GDMT implementation through SwedeHF', 'armGroupLabels': ['Screening through SwedeHF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Charlotta Ljungman, MD, PhD', 'role': 'CONTACT', 'email': 'charlotta.ljungman@vgregion.se'}], 'facility': 'Sahlgrenska Universitetssjukhuset', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Hemse', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ann Hoveland, MD', 'role': 'CONTACT', 'email': 'ann.hovland-tanneryd@gotland.se'}], 'facility': 'Hemse vårdcentral', 'geoPoint': {'lat': 57.23788, 'lon': 18.37443}}, {'city': 'Jönköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Patric Karlström, MD, PhD', 'role': 'CONTACT', 'email': 'patric.karlstrom@rjl.se'}], 'facility': 'Länssjukhuset Ryhov', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Camilla Hage, RN, PhD', 'role': 'CONTACT', 'email': 'camilla.hage@regionstockholm.se'}], 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ulrika Löfström, MD', 'role': 'CONTACT', 'email': 'ulrika.lofstrom@capiostgoran.se'}], 'facility': 'St Görans hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Carin Corovic Cabrera, MD, PhD', 'role': 'CONTACT', 'email': 'carin.corovic-cabrera@regionstockholm.se'}], 'facility': 'Södersjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Gianluigi Savarese, MD PhD', 'role': 'CONTACT', 'email': 'gianluigi.savarese@ki.se', 'phone': '\u202d+46 8-524 870 75\u202c'}, {'name': 'Camilla Hage, RN, PhD', 'role': 'CONTACT', 'email': 'camilla.hage@regionstockholm.se', 'phone': '\u202d+46 8-517 792 82\u202c'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Gianluigi Savarese', 'investigatorAffiliation': 'Region Stockholm'}}}}