Lead Investigator: Ricky Turgeon, University of British Columbia
Title of Proposal Research: Re-analyzing Heart Failure Treatment Outcomes Based on Patient Preferences: A Study Using Data from Multiple Clinical Trials
Vivli Data Request: 10997
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Heart failure (HF) is a serious condition affecting many adults worldwide, leading to poor quality of life, shorter life expectancy, and frequent hospitalizations. Patients with HF have multiple medication options, each with different benefits and risks. Deciding on the best treatment is complex for both patients and doctors, as it involves considering various factors, including survival, quality of life, and potential side effects.
Current clinical trials often assess medications based on broad outcomes, like the time to a significant event (such as death or hospitalization), but these trials can be difficult to interpret for individual patients because the impact of treatments can vary greatly. To address this, a new method called the “win ratio” has been developed. The win ratio compares different treatments by looking at several important outcomes, such as survival, side effects, and quality of life, and ranks them based on what matters most. This method allows us to weigh each treatment’s benefits and drawbacks more clearly, based on what is important to patients. For example, if a patient values living a longer life but is okay with a few side effects, the win ratio helps us determine which treatment provides the best balance of benefits.
However, no study has yet used patient preferences to decide which outcomes are the most important in the win ratio analysis. This is where our study comes in. We aim to re-analyze existing large clinical trials on HF treatments by incorporating patients’ personal preferences into the win ratio.
To do this, we will use a technique called discrete-choice experiments (DCEs). In a DCE, patients are asked to choose between different treatment options that vary based on key factors, such as how well the treatment helps the heart, how it affects their daily life, and whether there are side effects. For example, patients might be asked if they would prefer a treatment with a high chance of survival but some side effects, or a treatment with fewer side effects but less effective in improving health. This helps us understand what is most important to each patient in their treatment decision. By applying these preferences to the win ratio, we can better understand how different treatments perform according to what patients truly value.
In this way, we hope to make treatment decisions more personal and patient-centered, ensuring that treatments are better suited to the diverse needs and preferences of individuals with heart failure.
Requested Studies:
A Multicentre, Randomised, Double-blind, 90-day Superiority Trial to Evaluate the Effect on Clinical Benefit, Safety and Tolerability of Once Daily Oral EMPagliflozin 10 mg Compared to Placebo, Initiated in Patients Hospitalised for acUte Heart faiLure (de Novo or Decompensated Chronic HF) Who Have Been StabilisEd (EMPULSE)
Data Contributor: Boehringer Ingelheim
Study ID: NCT04157751
Sponsor ID: 1245-0204
A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
Data Contributor: Boehringer Ingelheim
Study ID: NCT03057951
Sponsor ID: 1245.110
A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Data Contributor: Boehringer Ingelheim
Study ID: NCT03057977
Sponsor ID: 1245.121