Clinical trial NCT04707261: Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)
Official title: A Prospective, Randomized, Double-blind, Multicenter Study on the Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anemia
Heart Failure
Keywords: Heart Failure
Anemia
Dapagliflozin
Lead sponsor: Xiangtan Central Hospital
Sponsor class: OTHER
Collaborators: name: Second Xiangya Hospital of Central South University
name: ZhuZhou Central Hospital
First posted: 2021-01-13
Enrollment: 1990
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female between the ages of 18 and 100 years.
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:

1. Treatment with SGLT2-i during the past 3 months of admission,or previous intolerance of an SGLT2 inhibitor.
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.

Primary outcomes:
measure: Composite number of hospital admissions for Heart Failure (HF) and all-cause death
timeFrame: 1 year
Secondary outcomes:
measure: Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score
timeFrame: Baselin, 3 months, 6 months, and 1 year
measure: Change in 6-minute walk distance (6MWD)
timeFrame: Baselin, 3 months, 6 months, and 1 year
measure: Change in hemoglobin
timeFrame: Baselin, 3 months, 6 months, and 1 year
Other outcomes:
Locations:
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
Study officials:
affiliation: Xiangtan Central Hospital
name: Jianping Zeng, Ph.D.
role: STUDY_CHAIR
affiliation: Second Xiangya Hospital of Central South University
name: Shenghua Zhou, Ph.D.
role: STUDY_DIRECTOR
affiliation: ZhuZhou Central Hospital
name: Chengming Wang, Ph.D.
role: STUDY_DIRECTOR
affiliation: The First People's Hospital of Xiangtan City
name: Fanghua Xu, M.D.
role: STUDY_DIRECTOR
affiliation: Xiangtan People's Hospital
name: Zhiqiang Cai, M.D.
role: STUDY_DIRECTOR
affiliation: Xiangxiang People's Hospital
name: Chonglun Zhou, M.D.
role: STUDY_DIRECTOR
References:
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.