NCT04707261

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,990 (estimated)
• Sponsor: Xiangtan Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia
• Heart Failure

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Participants will receive dapagliflozin 10 mg once daily
DRUG	Placebo	Participants will receive placebo 10 mg once daily

Timeline

• Start date: 2021-08-06
• Primary completion: 2025-05-05
• Completion: 2026-01-01
• First posted: 2021-01-13
• Last updated: 2024-07-01

Locations

1 site across 1 country: China