Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)
NCT ID: NCT04707261
Last Updated: 2024-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1990 participants
INTERVENTIONAL
2021-08-06
2026-01-01
Brief Summary
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Detailed Description
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Detailed 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.
This 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dapagliflozin
Dapagliflozin with standard-of-care therapies for heart failure, including sacubitril/valsartan or ACEI/ARB, beta-blocker, MRA, ICD and CRT
Dapagliflozin
Participants will receive dapagliflozin 10 mg once daily
Placebo
Standard-of-care therapies for heart failure, including sacubitril/valsartan or ACEI/ARB, beta-blocker, MRA, ICD and CRT
Placebo
Participants will receive placebo 10 mg once daily
Interventions
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Dapagliflozin
Participants will receive dapagliflozin 10 mg once daily
Placebo
Participants will receive placebo 10 mg once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Elevated NT-proBNP or BNP levels on admission.
3. Ejection fraction of 50% or less, and New York Heart Association (NYHA) class II, III, or IV symptoms.
Exclusion Criteria
2. Severe (eGFR \<30 mL/min/1.73 m\^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization.
3. Pregnant or breast feeding female patients.
18 Years
100 Years
ALL
No
Sponsors
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Second Xiangya Hospital of Central South University
OTHER
ZhuZhou Central Hospital
OTHER
Xiangtan Central Hospital
OTHER
Responsible Party
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Jianping Zeng
President of Xiangtan Centeral Hospital
Principal Investigators
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Jianping Zeng, Ph.D.
Role: STUDY_CHAIR
Xiangtan Central Hospital
Shenghua Zhou, Ph.D.
Role: STUDY_DIRECTOR
Second Xiangya Hospital of Central South University
Chengming Wang, Ph.D.
Role: STUDY_DIRECTOR
ZhuZhou Central Hospital
Fanghua Xu, M.D.
Role: STUDY_DIRECTOR
The First People's Hospital of Xiangtan City
Zhiqiang Cai, M.D.
Role: STUDY_DIRECTOR
Xiangtan People's Hospital
Chonglun Zhou, M.D.
Role: STUDY_DIRECTOR
Xiangxiang People's Hospital
Locations
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Xiangtan Central Hospital
Xiangtan, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2020/12/01
Identifier Type: -
Identifier Source: org_study_id
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