The Heart Failure Optimization Study (HF-OPT): rationale and design

Area of Science:

• Cardiology
• Heart Failure Research
• Medical Device Technology

Background:

• Current guidelines recommend delaying implantable cardioverter-defibrillator (ICD) implantation for primary prevention in heart failure with reduced ejection fraction (HFrEF) until optimal guideline-directed medical therapy (GDMT) is achieved for at least 3 months.
• Optimizing GDMT can extend beyond the initial 3-month period, necessitating further evaluation of cardiac function recovery.
• The Heart Failure Optimization Study (HF-OPT) addresses the need to understand left ventricular function recovery beyond this initial 3-month timeframe in newly diagnosed HFrEF patients.

Purpose of the Study:

• To assess the recovery of left ventricular ejection fraction (LVEF) in patients with newly diagnosed HFrEF.
• To evaluate the rate of LVEF improvement beyond 3 months of optimized GDMT.
• To determine if LVEF can recover to >35% between 90 and 180 days post-diagnosis.

Main Methods:

• The HF-OPT is a multicenter study with two non-randomized phases: a registry and a study phase.
• Patients receive a wearable cardioverter-defibrillator (WCD) for the first 90 days and are enrolled in a pre-study registry.
• Eligible patients undergo LVEF reassessment at 90, 180, and 360 days post-discharge. Approximately 600 subjects are planned for the study portion.

Main Results:

• The primary objective is to measure the rate of LVEF recovery to >35% between 90 and 180 days.
• Secondary endpoints include monitoring all-cause mortality and analyzing data from the WCD regarding arrhythmias and shocks.
• Approximately one-third of the ~600 enrolled subjects are expected to have reduced LVEF at the start of the study phase (day 90).

Conclusions:

• The HF-OPT study will provide crucial data on LVEF recovery rates between 90 and 180 days in HFrEF patients undergoing GDMT titration.
• Findings may inform clinical decisions regarding the timing and necessity of primary prophylactic ICD implantation.
• Understanding functional recovery is key to refining treatment strategies for HFrEF.