Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Randomized, Double-blind, Multicenter Study on the Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)

Conditions
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Anemia, Heart Failure

Intervention / Treatment
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* Drug: Dapagliflozin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapagliflozin<br>Dapagliflozin with standard-of-care therapies for heart failure, including sacubitril/valsartan or ACEI/ARB, beta-blocker, MRA, ICD and CRT | Drug: Dapagliflozin<br>* Participants will receive dapagliflozin 10 mg once daily<br>* Other names: FORXIGA;|
| Placebo Comparator: Placebo<br>Standard-of-care therapies for heart failure, including sacubitril/valsartan or ACEI/ARB, beta-blocker, MRA, ICD and CRT | Drug: Placebo<br>* Participants will receive placebo once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite number of hospital admissions for Heart Failure (HF) and all-cause death |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score | 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) | 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 | g/L | Baselin, 3 months, 6 months, and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Anemia, Dapagliflozin