The Post-Myocardial Infarction Pacing Remodeling Prevention Therapy (PRomPT) Trial: Design and Rationale
Eugene S Chung1, Trent M Fischer2, Fred Kueffer2
1Heart and Vascular Center, Christ Hospital, Cincinnati, Ohio.
Insights
Peri-infarct pacing may prevent heart failure after large myocardial infarction (MI). The PRomPT trial investigates if biventricular pacing reduces adverse cardiac remodeling and improves outcomes in MI patients.
Area of Science:
- Cardiology
- Biomedical Engineering
Background:
- Large myocardial infarctions (MI) pose a significant risk for heart failure development, despite medical advancements.
- Implantable cardioverter defibrillators reduce arrhythmic deaths post-MI but do not impact overall mortality.
- Novel interventions are crucial to decrease morbidity and mortality in large MI patients.
Purpose of the Study:
- To evaluate the efficacy of peri-infarct pacing in preventing adverse cardiac remodeling following myocardial infarction.
- To assess the impact of biventricular pacing on left ventricular remodeling and clinical outcomes in patients with large MI.
Main Methods:
- The Pacing Remodeling Prevention Therapy (PRomPT) trial randomizes up to 120 large MI patients to dual-site or single-site biventricular pacing or a control group.
- Left ventricular lead implantation in a peri-infarct region is performed within 10 days of MI.
- Primary endpoint: change in left ventricular end-diastolic volume at 18 months; secondary endpoints include heart failure hospitalizations, cardiovascular events, and mortality.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- The PRomPT trial aims to provide critical evidence on peri-infarct pacing's potential to mitigate adverse remodeling in large MI patients.
- Findings will inform future therapeutic strategies for improving outcomes in this high-risk population.
Background:
Despite considerable improvements in the medical management of patients with myocardial infarction (MI), patients with large MI still have substantial risk of developing heart failure. In the early post-MI setting, implantable cardioverter defibrillators have reduced arrhythmic deaths but have no impact on overall mortality. Therefore, additional interventions are required to further reduce the overall morbidity and mortality of patients with large MI.
Methods:
The Pacing Remodeling Prevention Therapy (PRomPT) trial is designed to study the effects of peri-infarct pacing in preventing adverse post-MI remodeling. Up to 120 subjects with peak creatine phosphokinase >3,000 U/L (or troponin T >10 μg/L) at time of MI will be randomized to either dual-site or single-site biventricular pacing with the left ventricular lead implanted in a peri-infarct region or to a nonimplanted control group. Those randomized to a device will be blinded to the pacing mode, but randomization to a device or control cannot be blinded. Subjects randomized to pacing will have the device implanted within 10 days of MI. The primary objective is to assess the change in left ventricular end-diastolic volume from baseline to 18 months. Secondary objectives are to assess changes in clinical and mechanistic parameters between the groups, including rates of hospitalization for heart failure and cardiovascular events, the incidence of sudden cardiac death and all-cause mortality, New York Heart Association functional class, 6-minute walking distance, and quality of life.
Conclusions:
The PRomPT trial will provide important evidence regarding the potential of peri-infarct pacing to interrupt adverse remodeling in patients with large MI.
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