Heart Failure
Conditions
Keywords
Dapagliflozin, acute heart failure
Brief 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.
Interventions
DRUGDapagliflozin
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 (
Sponsors
Chinese University of Hong Kong
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject age \>18 hospitalized for primary diagnosis of acute HF 2. Dyspnoea (exertional or at rest) and 1 of the following signs: * Congestion on chest X-ray * Rales on chest auscultation * Clinically relevant oedema (e.g. ≥1+ on a 0 to 3+ scale) * Elevated jugular venous pressure 3. NT-proBNP ≥300 ng/L (If ongoing atrial fibrillation/flutter at recruitment, NT-pro BNP must be ≥ 600 pg/mL.4. 5).
Exclusion criteria
1. Cardiogenic shock 2. Current hospitalization for acute HF primarily triggered by pulmonary embolism or cerebrovascular accident. 3. Interventions in the past 30 days prior or planned during the study: Major cardiac surgery, or TAVI, or PCI, or MitraClip 4. Current or expected heart transplant, LVAD, on IABP or other forms of mechanical support. 5. Haemodynamically severe uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study. 6. eGFR \<20 mL/min/1.73m2 as measured during index hospitalization (latest measurement before randomization) or patients requiring dialysis 7. Type 1 diabetes mellitus 8. History of ketoacidosis, including diabetic ketoacidosis 9. Prior treatment with SGLT2 inhibitors in 90 days prior to current admission. 10. Documented severe allergy or intolerance to SGLT2 inhibitors. 11. Pregnant subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in KCCQ-TSS | Change from baseline in KCCQ-TSS after 90 days of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in NYHA class | Change in NYHA class over 90 days of treatment | — |
| Days alive and out of hospital from study drug initiation | 90 days | — |
| Time to first occurrence of cardiovascular death or heart Dapa AHF study Ver. 1.4 dated 7Oct2022 2 failure event | 90 days | — |
| Occurrence of HHF | Occurrence of HHF until 90 days after initial hospital discharge | — |
| Change from baseline in log-transformed NT-proBNP level | Change from baseline in log-transformed NT-proBNP level over 90 days of treatment | — |
| Change from baseline in 6MWD | Change from baseline in 6MWD at 90 days | — |
| Cost effectiveness of early initiation of dapagliflozin for heart failure events avoided | 90 days | — |
| Clinical benefit | 90 days | a composite of all-cause mortality, number of heart failure events (including hospitalization for HFs, urgent heart failure visits and unplanned outpatient visits) |
| quality-of-life years (QALY) gained of dapagliflozin for heart failure events avoided | 90 days | — |
| 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. | Occurrence of Sustained eGFR until 90 days after initial hospital discharge | — |
Countries
Hong Kong
Outcome results
None listed