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. 2021 Dec 7;3(1):109–116. doi: 10.1016/j.hroo.2021.11.015

Table 2.

myPACE study endpoints

Primary outcome

  • Change in MLHFQ total scores at baseline, 1 month, and 1 year (categorical, relative, and absolute changes)

Secondary outcomes

  • NT-proBNP levels from baseline to 1 month after enrollment (categorical, absolute, and relative changes)

  • MLHFQ emotional score and physical score (categorical, absolute, and relative changes)

  • Pacemaker-monitored data over 1-year study period:
    • Atrial fibrillation/tachycardia burden
    • Pacemaker-detected activity levels by accelerometer
    • Thoracic impedance (surrogate marker for volume overload)
  • Clinical endpoints over 1-year study period (composite and individual):
    • Heart failure hospitalization or invasive outpatient intervention (intravenous loop diuretic)
    • Loop diuretic initiation or up-titration
    • Atrial fibrillation hospitalization or invasive outpatient intervention (emergency department visit for symptomatic or rapid atrial fibrillation or cardioversion)
    • Antiarrhythmic medication initiation or up-titration
    • Stroke or transient ischemic attack
    • Myocardial infarction

  • Blinding efficacy assessment at 1 month and 1 year

Adverse outcomes

  • Patient reported symptoms of palpitations or discomforts thought to be related to pacing

  • Worsening fatigue

  • Worsening heart failure symptoms

MLHFQ = Minnesota Living with Heart Failure Questionnaire; NT-proBNP = N-terminal pro–brain natriuretic peptide.