Ignite Creation Date:
2025-12-17 @ 1:44 PM
Ignite Modification Date:
2025-12-23 @ 9:49 PM
Study NCT ID:
NCT04707261
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2020-12-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1990}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2020-12-31', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite number of hospital admissions for Heart Failure (HF) and all-cause death', 'timeFrame': '1 year', 'description': 'Total number of deaths and heart failure hospitalizations in one year'}], 'secondaryOutcomes': [{'measure': 'Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score', 'timeFrame': 'Baselin, 3 months, 6 months, and 1 year', 'description': 'The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}, {'measure': 'Change in 6-minute walk distance (6MWD)', 'timeFrame': 'Baselin, 3 months, 6 months, and 1 year', 'description': 'This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.'}, {'measure': 'Change in hemoglobin', 'timeFrame': 'Baselin, 3 months, 6 months, and 1 year', 'description': 'g/L'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Anemia', 'Dapagliflozin'], 'conditions': ['Anemia', 'Heart Failure']}, 'referencesModule': {'references': [{'pmid': '33779938', 'type': 'DERIVED', 'citation': 'Zeng J, Zhu Y, Zhao W, Wu M, Huang H, Huang H, Wu C, Zhou X, Zhou S, Wang C, Yin K, Xu F, Cai Z, Li X, Cheng H, Xie Y, Tan Z, Hu X, Liao D, Wang Y. Rationale and Design of the ADIDAS Study: Association Between Dapagliflozin-Induced Improvement and Anemia in Heart Failure Patients. Cardiovasc Drugs Ther. 2022 Jun;36(3):505-509. doi: 10.1007/s10557-021-07176-0. Epub 2021 Mar 29.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to investigate the hemoglobin change and association between hemoglobin change and readmissions due to heart failure, and all-cause death in patients with heart failure treated with dapagliflozin or placebo.', 'detailedDescription': 'Study Description Brief Summary: The primary objective of this study is to investigate the hemoglobin change and association between hemoglobin change and readmissions due to heart failure, and all-cause death in patients with heart failure treated with dapagliflozin or placebo.\n\nDetailed Description: Heart failure is one of the most serious health concerns in the world, and it also remains the most common reason for hospitalization in older individuals. In patients with heart failure, anemia is associated with an increased risk of hospitalization and all-cause mortality. The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure (HF) events and cardiovascular death comparing to placebo in patients with reduced ejection fraction on top of standard of care.\n\nThis is an investigator-initiated, interventional, prospective, double-blind study. The primary objective is to investigate whether anemia correction is one of the prerequisites and determinants related to the beneficial effects of dapagliflozin in patients with heart failure. Impact of dapagliflozin treatment on hemoglobin level, heart failure-related readmission and all-cause death will be observed in comparison with placebo in heart failure patients receiving guideline recommended standard therapy during the 3months, 6 months and 1 year follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female between the ages of 18 and 100 years.\n2. Elevated NT-proBNP or BNP levels on admission.\n3. Ejection fraction of 50% or less, and New York Heart Association (NYHA) class II, III, or IV symptoms.\n\nExclusion Criteria:\n\n1. Treatment with SGLT2-i during the past 3 months of admission,or previous intolerance of an SGLT2 inhibitor.\n2. Severe (eGFR \\<30 mL/min/1.73 m\\^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization.\n3. Pregnant or breast feeding female patients.'}, 'identificationModule': {'nctId': 'NCT04707261', 'acronym': 'ADIDAS', 'briefTitle': 'Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)', 'organization': {'class': 'OTHER', 'fullName': 'Xiangtan Central Hospital'}, 'officialTitle': 'A Prospective, Randomized, Double-blind, Multicenter Study on the Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)', 'orgStudyIdInfo': {'id': '2020/12/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin', 'description': 'Dapagliflozin with standard-of-care therapies for heart failure, including sacubitril/valsartan or ACEI/ARB, beta-blocker, MRA, ICD and CRT', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Standard-of-care therapies for heart failure, including sacubitril/valsartan or ACEI/ARB, beta-blocker, MRA, ICD and CRT', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'otherNames': ['FORXIGA'], 'description': 'Participants will receive dapagliflozin 10 mg once daily', 'armGroupLabels': ['Dapagliflozin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive placebo 10 mg once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '411100', 'city': 'Xiangtan', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianping Zeng, Ph.D.', 'role': 'CONTACT', 'email': '46595842@qq.com', 'phone': '+8615292271982'}], 'facility': 'Xiangtan Central Hospital', 'geoPoint': {'lat': 27.85, 'lon': 112.9}}], 'centralContacts': [{'name': 'Jianping Zeng, Ph.D.', 'role': 'CONTACT', 'email': '46595842@qq.com', 'phone': '+86 15292271982'}], 'overallOfficials': [{'name': 'Jianping Zeng, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Xiangtan Central Hospital'}, {'name': 'Shenghua Zhou, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Xiangya Hospital of Central South University'}, {'name': 'Chengming Wang, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ZhuZhou Central Hospital'}, {'name': 'Fanghua Xu, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': "The First People's Hospital of Xiangtan City"}, {'name': 'Zhiqiang Cai, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Xiangtan People's Hospital"}, {'name': 'Chonglun Zhou, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Xiangxiang People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangtan Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Second Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'ZhuZhou Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President of Xiangtan Centeral Hospital', 'investigatorFullName': 'Jianping Zeng', 'investigatorAffiliation': 'Xiangtan Central Hospital'}}}}