Novel Trial Design: CHIEF-HF
Why the study?
The high expense of traditional clinical trials creates a need for new strategies, such as decentralized designs using mobile technologies, to efficiently generate evidence and test novel therapies in heart failure.
Does canagliflozin improve heart failure symptoms in patients with heart failure regardless of ejection fraction or diabetes status?
Comparison
Canagliflozin 100 mg daily vs matching placebo
Design
Decentralized, patient-centered randomized clinical trial
Follow-up
12 weeks
Authors
Discussion
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Member takes
Implication
Canagliflozin improves HF symptom burden regardless of EF or diabetes; extends SGLT2i evidence and validates decentralized RCTs for efficient trials.
Structured PICO
Does canagliflozin improve heart failure symptoms in patients with heart failure regardless of ejection fraction or diabetes status?
P
Population
1,900 patients with a medical record-confirmed diagnosis of heart failure, stratified by reduced (≤40%) or preserved (>40%) ejection fraction, regardless of diabetes status
I
Intervention
Canagliflozin 100 mg daily for 12 weeks
C
Comparator
Matching placebo
O
Outcome
12-week change in the total symptom score of the Kansas City Cardiomyopathy Questionnairepatient reported
The CHIEF-HF trial introduces a novel decentralized, patient-centered design using mobile technologies to evaluate canagliflozin for heart failure symptoms.
Cite This Study
Spertus et al. (2021) studied this question.