Guideline-directed medical therapy (GDMT) and the mortality benefit it provides in the heart failure with reduced ejection fraction (HFrEF) population are well-established by multiple professional society guidelines. GDMT refers to initial medical therapy with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin-receptor blockers (ARB), beta-blockers (BB), and mineralocorticoid receptor antagonists (MRA) titrating to maximally tolerated doses for patients with HFrEF. Cardiac implantable electronic devices (CIEDs) such as the implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT) have also become a mainstay in the management of HFrEF after implementation of GDMT. ICD therapy is an effective and established treatment for HFrEF patients for both primary and secondary prevention of SCD. Regarding the use, adherence and results of GDMT after ICD/CRT implantation, there is very limited data available in the literature. There are a few retrospective trials that show this, however very limited randomized controlled data. This proposed study would randomize patients with primary prevention ICDs and CRT into a specialized clinic with a heart failure nurse practitioner vs usual clinical care, with the goal of determining outcomes such as change in LVEFs, heart failure hospitalizations, and visits to the ER for heart failure. Consequently, this would determine whether targeted clinics are needed for ICD/CRT patients with HFrEF to optimize GDMT, improve patient outcomes and thus implement new guidelines/recommendations for this specific patient population.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in Left Ventricular Ejection Fraction (LVEF)
Timeframe: 1 year