Clinical cardiology · 2026
Rationale and Design of the Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure.
СтатьяРандомизированное исследованиеPragmatic Clinical TrialНазвание и аннотация: Перевод пока не подготовлен
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Blood Alexander J, Unlu Ozan, Ostrominski John W, Hassan Shahzad, Nichols Hunter, Subramaniam Samantha, Gabovitch Daniel, Chasse Jacqueline, McPartlin Marian, Figueroa Christian, Collins Emma, Twining Megan, Varugheese Matthew, Wagholikar Kavishwar, Cannon Christopher P, Desai Akshay S, Scirica Benjamin M
Аннотация
BACKGROUND: Despite overwhelming evidence of clinical benefit for patients with heart failure (HF), the uptake of guideline-directed medical therapies (GDMT) has been slow. Collaborative approaches are critically needed to improve alignment between evidence and clinical practice. Many strategies proposed to improve GDMT implementation have been either ineffective or too resource-intensive to implement at scale across different practice contexts. Furthermore, most existing approaches focus primarily on patients with HF and reduced EF, despite growing evidence for effective pharmacologic therapy in those with HF and mildly reduced or preserved ejection fraction (HFpEF).
HYPOTHESIS: Based on this experience, we designed the Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure (COPILOT-HF) study (NCT05734690).
METHODS: This is a pragmatic, randomized, open-label intervention trial to compare a comprehensive, remote, navigator-led, algorithm-driven strategy for optimization of GDMT prescribing in patients with HF across the full spectrum of ejection fraction with a control intervention focused on patient and provider education regarding the importance of GDMT optimization.
RESULTS: The primary efficacy endpoint of the study is the proportion of patients receiving optimal HF treatment at 3 months. Additional outcomes of interest include the proportion of patients with optimal HF therapy at 6 months and 12 months as well as health resource utilization, including hospitalizations and deaths.
CONCLUSIONS: COPILOT-HF will evaluate the effectiveness of an early implementation of a remote pharmacist-led medication titration strategy across the HF spectrum.
HYPOTHESIS: Based on this experience, we designed the Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure (COPILOT-HF) study (NCT05734690).
METHODS: This is a pragmatic, randomized, open-label intervention trial to compare a comprehensive, remote, navigator-led, algorithm-driven strategy for optimization of GDMT prescribing in patients with HF across the full spectrum of ejection fraction with a control intervention focused on patient and provider education regarding the importance of GDMT optimization.
RESULTS: The primary efficacy endpoint of the study is the proportion of patients receiving optimal HF treatment at 3 months. Additional outcomes of interest include the proportion of patients with optimal HF therapy at 6 months and 12 months as well as health resource utilization, including hospitalizations and deaths.
CONCLUSIONS: COPILOT-HF will evaluate the effectiveness of an early implementation of a remote pharmacist-led medication titration strategy across the HF spectrum.