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)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Anemia
• Intervention / Treatment: Drug: Dapagliflozin; Drug: 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.

• Study Type: Interventional
• Enrollment (Estimated): 1990
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jianping Zeng, Ph.D.; Phone Number: +86 15292271982; Email: 46595842@qq.com

Study Locations

• China
  • 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: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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	Drug: Dapagliflozin; Participants will receive dapagliflozin 10 mg once daily; Other Names: FORXIGA
Placebo Comparator: Placebo; Standard-of-care therapies for heart failure, including sacubitril/valsartan or ACEI/ARB, beta-blocker, MRA, ICD and CRT	Drug: Placebo; Participants will receive placebo 10 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite number of hospital admissions for Heart Failure (HF) and all-cause death	Total number of deaths and heart failure hospitalizations in one year	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

Collaborators and Investigators

• Sponsor: Xiangtan Central Hospital
• Collaborators: ZhuZhou Central Hospital; Second Xiangya Hospital of Central South University
• 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

General Publications

• Zeng J, Zhu Y, Zhao W, Wu M, Huang H, Huang H, Wu C, Zhou X, Zhou S, Wang C, Yin K, Xu F, Cai Z, Li X, Cheng H, Xie Y, Tan Z, Hu X, Liao D, Wang Y. Rationale and Design of the ADIDAS Study: Association Between Dapagliflozin-Induced Improvement and Anemia in Heart Failure Patients. Cardiovasc Drugs Ther. 2022 Jun;36(3):505-509. doi: 10.1007/s10557-021-07176-0. Epub 2021 Mar 29.

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Estimated): May 5, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure; Dapagliflozin; Anemia
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Hematologic Diseases; Heart Failure; Anemia; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: 2020/12/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No