- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04707261
Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS) (ADIDAS)
A Prospective, Randomized, Double-blind, Multicenter Study on the Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jianping Zeng, Ph.D.
- Phone Number: +86 15292271982
- Email: 46595842@qq.com
Study Locations
-
-
Hunan
-
Xiangtan, Hunan, China, 411100
- Recruiting
- Xiangtan Central Hospital
-
Contact:
- Jianping Zeng, Ph.D.
- Phone Number: +8615292271982
- Email: 46595842@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female between the ages of 18 and 100 years.
- Elevated NT-proBNP or BNP levels on admission.
- Ejection fraction of 50% or less, and New York Heart Association (NYHA) class II, III, or IV symptoms.
Exclusion Criteria:
- Treatment with SGLT2-i during the past 3 months of admission,or previous intolerance of an SGLT2 inhibitor.
- Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization.
- Pregnant or breast feeding female patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dapagliflozin
Dapagliflozin with standard-of-care therapies for heart failure, including sacubitril/valsartan or ACEI/ARB, beta-blocker, MRA, ICD and CRT
|
Participants will receive dapagliflozin 10 mg once daily
Other Names:
|
Placebo Comparator: Placebo
Standard-of-care therapies for heart failure, including sacubitril/valsartan or ACEI/ARB, beta-blocker, MRA, ICD and CRT
|
Participants will receive placebo once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite number of hospital admissions for Heart Failure (HF) and all-cause death
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time Frame: Baselin, 3 months, 6 months, and 1 year
|
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.
|
Baselin, 3 months, 6 months, and 1 year
|
Change in 6-minute walk distance (6MWD)
Time Frame: Baselin, 3 months, 6 months, and 1 year
|
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
|
Baselin, 3 months, 6 months, and 1 year
|
Change in hemoglobin
Time Frame: Baselin, 3 months, 6 months, and 1 year
|
g/L
|
Baselin, 3 months, 6 months, and 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jianping Zeng, Ph.D., Xiangtan Central Hospital
- Study Director: Shenghua Zhou, Ph.D., Second Xiangya Hospital of Central South University
- Study Director: Chengming Wang, Ph.D., ZhuZhou Central Hospital
- Study Director: Fanghua Xu, M.D., The First People's Hospital of Xiangtan City
- Study Director: Zhiqiang Cai, M.D., Xiangtan People's Hospital
- Study Director: Chonglun Zhou, M.D., Xiangxiang People's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/12/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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