An observational study in Heart Failure, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-02-16.
Sponsored by Chinese University of Hong Kong · Observational
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 1,678 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This is based on the primary objective and calculation
Dyspnoea (exertional or at rest) and 1 of the following signs:
Exclusion Criteria:
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 (
Change from baseline in KCCQ-TSS
Time frame: Change from baseline in KCCQ-TSS after 90 days of treatment.
Change from baseline in log-transformed NT-proBNP level
Time frame: Change from baseline in log-transformed NT-proBNP level over 90 days of treatment
Change in NYHA class
Time frame: Change in NYHA class over 90 days of treatment
Days alive and out of hospital from study drug initiation
Time frame: 90 days
Days alive and out of hospital from study drug initiation
Time frame: Days alive and out of hospital from study drug initiation until 90 days after randomization
Time to first occurrence of cardiovascular death or heart Dapa AHF study Ver. 1.4 dated 7Oct2022 2 failure event
Time frame: 90 days
Occurrence of HHF
Time frame: Occurrence of HHF until 90 days after initial hospital discharge
Occurrence of Sustained eGFR reduction of ≥40% eGFR, or - Sustained eGFR <15mL/min/1.73m2 for patients with baseline eGFR ≥30 mL/min/1.73m2 - Sustained eGFR <10mL/min/1.73m2 for patients with baseline eGFR <30 mL/min/1.73m2.
Time frame: Occurrence of Sustained eGFR until 90 days after initial hospital discharge
Change from baseline in 6MWD
Time frame: Change from baseline in 6MWD at 90 days
Cost effectiveness of early initiation of dapagliflozin for heart failure events avoided
Time frame: 90 days
Clinical benefit
a composite of all-cause mortality, number of heart failure events (including hospitalization for HFs, urgent heart failure visits and unplanned outpatient visits)
Time frame: 90 days
quality-of-life years (QALY) gained of dapagliflozin for heart failure events avoided
Time frame: 90 days
Plan to share: Undecided
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Chinese University of Hong Kong