SIDAMI - Sildenafil and Diastolic Dysfunction After Acute Myocardial Infarction (AMI)

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

In patients with Doppler echocardiographic signs of elevated LV filling pressures despite preserved LV systolic function after AMI treatment with the phosphodiesterase inhibitor sildenafil 40 mg three times daily for 9 weeks will compared with placebo

1. Improve resting LV filling and cardiac hemodynamics.

2. Improve exercise capacity.

3. Improve filling pattern and cardiac hemodynamics during exercise.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jacob E Mueller
• Collaborator: Rigshospitalet, Denmark
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• Age >50 years

• Recent AMI (within 21 days) defined according to ESC/ACC guidelines

• Doppler echocardiographic signs of elevated filling pressures defined as

• diastolic E/e' ratio >15, or

• diastolic E/e' ratio 8-15 and left atrial volume index>32 ml/m2

• Preserved LV systolic function (EF>45%)

• Written informed consent

Exclusion Criteria:

• Ongoing myocardial ischemia

• Ongoing treatment with nitrates.

• Poor echocardiographic window

• Inability to exercise

• Permanent atrial fibrillation or paced rhythm

• Planned coronary artery bypass grafting

• Other noncardiac condition with expected survival less than 6 months

• Unwilling to participate

• Known intolerance to sildenafil

• Non-arteritic anterior ischaemic optic neuropathy