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J Card Fail. 2015 Jul;21(7):601-7. doi: 10.1016/j.cardfail.2015.03.005. Epub 2015 Mar 18.

The Post-Myocardial Infarction Pacing Remodeling Prevention Therapy (PRomPT) Trial: Design and Rationale.

Author information

1
Heart and Vascular Center, Christ Hospital, Cincinnati, Ohio. Electronic address: chunge@ohioheart.org.
2
Medtronic, Minneapolis, Minnesota.
3
VA Medical Center, University of Minnesota, Minneapolis, Minnesota.
4
Leiden University Medical Center, Leiden, The Netherlands.
5
Medical University of South Carolina, Charleston, South Carolina.
6
Gorman Cardiovascular Research Group, Perelman School of Medicine, University of Pennsylvania, Smilow Center for Translational Research, Philadelphia, Pennsylvania.
7
Charité Universitätsmedizin, Berlin, Germany.
8
Tufts University School of Medicine, Tufts Medical Center, Boston, Massachusetts.
9
Department of Cardiology, Eastern Slovakia Institute for Cardiac and Vascular Diseases, Kosice, Slovakia.
10
Rigshospitalet, Copenhagen and University of Copenhagen, Copenhagen, Denmark.
11
New York-Presbyterian Hospital, Columbia University Medical Center, New York, New York.
12
Emory University Hospital Midtown, Emory University School of Medicine, Atlanta, Georgia.

Abstract

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.

KEYWORDS:

Myocardial infarction; adverse remodeling; heart failure; pacing

PMID:
25795507
DOI:
10.1016/j.cardfail.2015.03.005
[Indexed for MEDLINE]

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