Health TrialsbyHealthPanel

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

ConditionsAnemiaHeart Failure
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorXiangtan Central Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 m² by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization.

Pregnant or breast feeding female patients.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin

    Drug

    Participants will receive dapagliflozin 10 mg once daily

  • Placebo

    Drug

    Participants will receive placebo 10 mg once daily

Treatment groups

1,990 Participants
are divided into 2 treatment groups
Group A: DapagliflozinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite number of hospital admissions for Heart Failure (HF) and all-cause death

Total number of deaths and heart failure hospitalizations in one year

Time frame
1 year

Secondary outcomes

1

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.

Time frame
Baselin, 3 months, 6 months, and 1 year
2

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.

Time frame
Baselin, 3 months, 6 months, and 1 year
3

Change in hemoglobin

g/L

Time frame
Baselin, 3 months, 6 months, and 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiangtan Central Hospital

Lead sponsor

Second Xiangya Hospital of Central South University

Collaborator

ZhuZhou Central Hospital

Collaborator

Source ClinicalTrials.gov
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