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

R Sanchez1, D Duncker2, B Colley3

  • 1HCA Florida Heart Institute, St. Petersburg, FL, USA.

Herzschrittmachertherapie & Elektrophysiologie
|January 25, 2023
PubMed

Insights

This study evaluates left ventricular function recovery in heart failure patients after 3 months of optimal medical therapy. Results may influence decisions on implantable cardioverter-defibrillator implantation for primary prevention.

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.
Abstract

Keywords:
Guideline-directed medical therapyImplantable cardioverter-defibrillatorLeft ventricular ejection fractionWearable cardioverter-defibrillator

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