Speaker
John Spertus, MD, MPH, FACC, FAHA
Daniel Lauer/Missouri Endowed Chair and Professor
University of Missouri – Kansas City
Clinical Director of Outcomes Research
Saint Luke’s Mid America Heart Institute
Keywords
Heart failure; Canagliflozin; INVOKANA; Kansas City Cardiomyopathy Questionnaire (KCCQ); tele-health; tele-trials
Key Points
- The CHIEF-HF trial (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure) was a double blind randomized clinical trial of the medication Canagliflozin for heart failure.
- CHIEF-HF was designed to learn if patients have fewer symptoms after 3 months of treatment with Canagliflozin.
- CHIEF-HF used a novel trial design that involved no site-visits and electronic monitoring of patient engagement. The follow up rate for this study was over 97%.
- The Total Symptom Score on the KC Cardiomyopathy Questionnaire was the key outcome measure in the CHIEF-HF Trial.
- Heart failure patients treated with Canagliflozin experienced a statistically significant improvements in symptoms.
- Sites in the study chose recruitment methods that worked best for them. More personalized recruitment strategies were most successful.
- Difficulties of electronic trials include the technology limitations of the participants, and electronic consent concerns from regulatory agencies. Positives of electronic trials are high enrollment and completion rates.
Discussion Themes
How do technology heavy studies enroll diverse and underserved populations who may not have access to smartphones and wearable technology?
Virtual studies such as this that enrolled at 6 to 8 times the rate on a traditional trial can save quite a bit of money on overhead expenses.
Read more about the CHIEF-HF trial.
Tags
#pctGR, @Collaboratory1