Sildenafil and diastolic dysfunction after acute myocardial infarction trial: Rationale and Design

TY - JOUR

T1 - Sildenafil and diastolic dysfunction after acute myocardial infarction trial

T2 - Rationale and Design

AU - Andersen, Mads J

AU - Gustafsson, Finn

AU - Hassager, Christian

AU - Køber, Lars

AU - Møller, Jacob E

PY - 2013/4

Y1 - 2013/4

N2 - Aims Diastolic dysfunction following myocardial infarction is an important predictor of outcome, irrespective of left ventricular systolic function. Previous studies suggest that phosphordiesterase-5 inhibition has a favorable effect on the myocardium as well as on the pulmonary and systemic vasculature. Methods Patients ≥50 years old with recent myocardial infarction, preserved left ventricular ejection fraction (≥45%), and echocardiographic evidence of diastolic dysfunction (ratio between early [E] transmitral filling velocity and early diastolic tissue Doppler velocity [e′] ≥8 and left atrial volume ≥34 mL/m2) will be double-blindly randomized 1:1 to receive 9 weeks of treatment with 40 mg sildenafil, 3 times per day, or comparable placebo. Before randomization and after 9 weeks of treatment, resting Doppler echocardiography, resting right heart catheterization, and symptom-limited supine cycle exercise testing with simultaneous echocardiography and right heart catheterization will be performed. The primary end point is filling pressure at rest and at peak exercise. Statistics With a power of 80% and a significance level of.05, a study group of 60 patients is needed to detect a 15% reduction at peak exercise, which is considered clinically relevant. To account for dropouts and noncompliance, 70 patients will be enrolled in the study. Conclusions In addition to determining if sildenafil can reduce filling pressure at rest and at peak exercise, the Sildenafil and Diastolic Dysfunction After Acute Myocardial Infarction trial will provide additional hemodynamic information to help phenotypically classify this growing population of patients with diastolic dysfunction and preserved ejection fraction following myocardial infarction.

AB - Aims Diastolic dysfunction following myocardial infarction is an important predictor of outcome, irrespective of left ventricular systolic function. Previous studies suggest that phosphordiesterase-5 inhibition has a favorable effect on the myocardium as well as on the pulmonary and systemic vasculature. Methods Patients ≥50 years old with recent myocardial infarction, preserved left ventricular ejection fraction (≥45%), and echocardiographic evidence of diastolic dysfunction (ratio between early [E] transmitral filling velocity and early diastolic tissue Doppler velocity [e′] ≥8 and left atrial volume ≥34 mL/m2) will be double-blindly randomized 1:1 to receive 9 weeks of treatment with 40 mg sildenafil, 3 times per day, or comparable placebo. Before randomization and after 9 weeks of treatment, resting Doppler echocardiography, resting right heart catheterization, and symptom-limited supine cycle exercise testing with simultaneous echocardiography and right heart catheterization will be performed. The primary end point is filling pressure at rest and at peak exercise. Statistics With a power of 80% and a significance level of.05, a study group of 60 patients is needed to detect a 15% reduction at peak exercise, which is considered clinically relevant. To account for dropouts and noncompliance, 70 patients will be enrolled in the study. Conclusions In addition to determining if sildenafil can reduce filling pressure at rest and at peak exercise, the Sildenafil and Diastolic Dysfunction After Acute Myocardial Infarction trial will provide additional hemodynamic information to help phenotypically classify this growing population of patients with diastolic dysfunction and preserved ejection fraction following myocardial infarction.

U2 - 10.1002/clc.22103

DO - 10.1002/clc.22103

M3 - Journal article

C2 - 23450513

SN - 0160-9289

VL - 36

SP - 179

EP - 183

JO - Clinical Cardiology

JF - Clinical Cardiology

IS - 4

ER -