We are currently enrolling participants into a virtual clinical research study looking at an investigational study medication for heart failure.
About the CHIEF-HF Study
The CHIEF-HF study is enrolling participants from large, integrated healthcare networks and large physician practices in the United States. The majority of study-related activities will take place through an app on a smartphone and actigraphy data from a Fitbit device. There will be no in-person clinic visits required by the study.
As a member of your healthcare network, you may have patients who have been contacted about the CHIEF-HF study and asked to take a short survey to see if they qualify.
The CHIEF-HF study is evaluating the impact of an investigational medicine on health status, quality of life, and functional status in heart failure.
The study consists of 3 main periods:
- Screening Period – After providing informed consent, study screening may last up to 3 weeks. During this time, participants’ medical history will be reviewed to confirm eligibility criteria.
- Double-Blind Treatment Period – Approximately 1,900 participants from the U.S. will be randomized into the study in a 1:1 ratio to take the investigational medicine or placebo for 3 months. Participants will wear a Fitbit device and perform study assessments such as ePROs, drug accountability, and satisfaction survey via a smartphone app. Other medical information will be collected through insurance claims data.
- Follow-Up Period – After the end of the double-blind treatment period, the study will continue for an additional 6 months when study intervention will no longer be provided. Data collection from claims, smartphone, the Fitbit device, and ePROs will continue until month 9 for the purpose of secondary and further exploratory endpoints analyses.
Synopsis, Objectives and Endpoints of the CHIEF-HF study
An improvement in patient’s symptoms of HF would be an important advance in the clinical management of HF. This randomized study is designed to assess whether an SGLT2 inhibitor improves HF symptoms as assessed by the Total Symptom Score (TSS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ) patient reported outcome (PRO) scale in participants with HF and with or without T2DM in a real-world setting.
- to determine the superiority of the effectiveness of the study medication versus placebo in participants with symptomatic HF in improving the overall KCCQ TSS.
- to determine the superiority of the effectiveness of the study medication versus placebo in improving the total daily step count.
- to determine the superiority of the effectiveness of the study medication versus placebo in improving the KCCQ individual domain scores (physical limitation, quality of life, clinical summary, and overall).
In order to participate, patients must meet the following basic criteria:
- Be 18 years of age or older,
- Have clinically stable, symptomatic HF with or without T2DM with a KCCQ score of >40 and <80 prior to randomization.
More information about the study is available for healthcare providers at clinicaltrials.gov, using the search term “CHIEF-HF”. If your patient, who was referred to the study, has not already done so, please encourage them to complete the pre-screening questionnaire at www.chiefhf-study.com. Please do not refer other patients who have not been previously contacted about the study as they will not be eligible.