Guideline Directed Medical Therapy in Heart Failure Trials: A New Proposed Scoring System

Abstract

Background Current guidelines recommend multiple drugs titrated to maximally-tolerated dose as Guideline Directed Medical Therapy (GDMT) for chronic heart failure (HF). In clinical trials, background therapy at randomization is often stated as being “optimized” but objective criteria supporting such assertion are lacking. We propose a simple scoring system to define GDMT, set thresholds for optimal therapy, and standardize comparisons across HF clinical trials. Methods We evaluated current ACC/AHA/HFSA and ESC HF guidelines and the GDMT definition in 8 HF drug and device trials. We created a score based on strength of evidence, literature review, and data regarding dose effects. The score was tested in 10 hypothetical clinical scenarios based on likely drug combinations in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) Trial. Results Figure 1 shows the proposed score. Of the 10 clinical scenarios based on COAPT, 3 patients were not optimized according to the proposed score. The score performed well in defining GDMT in most of these clinical scenarios. Conclusion We propose a simple score for measuring GDMT, which validates well in clinical scenarios from a modern clinical trial. Utilizing this system will help establish a quality threshold for background therapy according to guideline recommendations, and provide standards for comparison across clinical trials. Further research should be conducted to determine whether the proposed score correlates with clinical outcomes.