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

Heart Failure Clinical Trial

— ADIDAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04707261
• Other study ID #: 2020/12/01
• Status: Recruiting
• Phase: Phase 4
• Start date: August 6, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: Xiangtan Central Hospital
• Contact: Jianping Zeng, Ph.D.
• Phone: +86 15292271982
• Email: 46595842[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1990
• Est. completion date: January 1, 2025
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Heart Failure

Intervention

Drug:
• Dapagliflozin
Participants will receive dapagliflozin 10 mg once daily
• Placebo
Participants will receive placebo once daily

Locations

Country	Name	City	State
China	Xiangtan Central Hospital	Xiangtan	Hunan

Sponsors (3)

Lead Sponsor	Collaborator
Xiangtan Central Hospital	Second Xiangya Hospital of Central South University, ZhuZhou Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite number of hospital admissions for Heart Failure (HF) and all-cause death		1 year
Secondary	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
Secondary	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
Secondary	Change in hemoglobin	g/L	Baselin, 3 months, 6 months, and 1 year