NCT05759000

Dapa Acute Heart Failure Study

The Effect of Early Inpatient Initiation of Dapagliflozin on the Health-related Quality of Life of Patients With Heart Failure With All Range of Ejection Fraction: a Local Registry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Heart failure (HF) is one of the most important reasons for hospital admission and is associated with high mortality and morbidity. After discharge, up to 40% of patients are readmitted within 6 months and 1-year post-discharge mortality is high. The cost burden of treating patients with HF is high and \~80% of healthcare costs are related to hospital admissions. Sodium-glucose cotransporter-2 (SGLT2) inhibitor is considered one of the four foundational therapies (ACE-I or ARNI, beta-blockers, MRA, and SGLT2 inhibitors) for HFrEF. This is an investigator-initiated, prospective, single-centre, registry that evaluates the change in HRQL as measured by the KCCQ-TSS after the initiation of Dapagliflozin.

Detailed description

Heart failure (HF) is one of the most important reasons for hospital admission and is associated with high mortality and morbidity and poor quality of life (1). After discharge, up to 40% of patients are readmitted within 6 months and 1-year post-discharge mortality is high (2-4). The cost burden of treating patients with HF is high and \~80% of healthcare costs are related to hospital admissions (5). Sodium-glucose cotransporter-2 (SGLT2) inhibitor is considered one of the four foundational therapies (ACE-I or ARNI, beta-blockers, MRA, and SGLT2 inhibitors) for HFrEF (6) However, guidelines do not specify the sequence and the timing of which therapy to be commenced. In particular, dapagliflozin has been shown in randomized controlled trials to reduce the combined risk of cardiovascular death or HF hospitalization and improve quality of life in HF patients with both reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF), respectively, regardless of the presence or absence of diabetes in the DAPA-HF and PRESERVED-HF trials (7, 8). HF patient usually has poor QoL, and health-related quality of life (HRQL) measure has been shown to be associated with all cause death and HF hospitalization in a multinational study (9). There exist a geographical and ethnical variation in patients HRQL and clinical outcomes amongst various countries (9). The Kansas City Cardiomyopathy Questionnaire-total symptom scores (KCCQ-TSS) is a simple, widely available, and inexpensive tool that characterizes a patient's HF-related health status. Showing that it can be used as a marker to predict major clinical outcomes in a wide spectrum of patients with HF across the world would confirm its usefulness in research as well as in clinical practice.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Sodium-glucose cotransporter-2 (SGLT2) inhibitor is considered one of the four foundational therapies (ACE-I or ARNI, beta-blockers, MRA, and SGLT2 inhibitors) for HFrEF (6). However, guidelines do not specify the sequence and the timing of which therapy to be commenced. In particular, dapagliflozin has been shown in randomized controlled trials to reduce the combined risk of cardiovascular death or HF hospitalization and improve quality of life in HF patients with both reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF), respectively, regardless of the presence or absence of diabetes in the DAPA-HF and DELIVER trials (

Timeline

• Start date: 2023-04-09
• Primary completion: 2025-09-09
• Completion: 2025-12-09
• First posted: 2023-03-08
• Last updated: 2024-02-16

Locations

1 site across 1 country: Hong Kong