SGLT2i improves symptoms in HF

The Canagliflozin Impact On Health Status, Quality Of Life And Functional Status In Heart Failure Clinical Trial

Presented at the American Heart Association’s Scientific Sessions 2021 by: Prof. John Spertus, MD - Kansas City, MO, USA

Introduction and methods

Aim of the study

Treatment goals in HF are not limited to reducing disease progression, hospitalizations and mortality. Improving the patient’s symptoms, functional status and quality of life are equally important. The CHIEF-HF study investigated whether canagliflozin improves the symptoms of patients with HF over 3 months of treatment.

Study design

CHIEF-HF was a completely virtual randomized trial without any face-to-face visits. A total of 476 patients (mean age was 63.4 years and 44.9% were women) with HF (HFrEF and HFpEF, with or without T2DM) were randomized 1:1, stratified by HFrEF vs. HFpEF, to 100 mg of canagliflozin or placebo for 12 weken. Study drugs were mailed directly to the participants. Participants filled in the Kansas City Cardiomyopathy Questionnaire (KCCQ) at randomization and at 2, 4, 6 and 12 weeks using a smartphone app.

Outcomes

The primary outcome was change in KCCQ Total Symptom Scores (KCCQ-TSS) at 12 weeks.

Main results

• Canagliflozin significantly improved KCCQ-TSS at 12 weeks compared to placebo with a difference of 4.3 points (95% CI 0.80-7.80, P = 0.016). This difference between the two groups was visible as early as 2 weeks.
• The observed benefit with canagliflozin on KCCQ-TSS was consistent in all subgroups, including patients with HFrEF and HFpEF, and in patients with and without T2DM (P for interaction = 0.35 and 0.90, respectively).

Conclusion

Canagliflozin improved symptoms in HF as measured by KCCQ-TSS, regardless of EF or diabetes status. The benefits with canagliflozin were observed as early as 2 weeks and sustained until the end of treatment at 3 months. Prof. John Spertus, MD said that this virtual RCT allowed for a more rapid enrollment and completion compared to traditional RCTs. It thereby models a new approach to conduct RCTs.

-Our reporting is based on the information provided at the American Heart Association’s Scientific Sessions 2021-