Sildenafil and diastolic dysfunction after AMI - SIDAMI

Phase 1

• Conditions: Diastolic dysfunction; MedDRA version: 9.1Level: LLTClassification code 10052337Term: Diastolic dysfunction; MedDRA version: 9.1Level: PTClassification code 10052337Term: Diastolic dysfunction

• Registration Number: EUCTR2009-011006-42-DK
• Lead Sponsor: Rigshospitalet, Hjertemedicinsk afd. B

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-23
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

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
odiastolic E/e’ ratio >15, or
odiastolic E/e’ ratio 8-15 and left atrial volume index>32 ml/m2
·Preserved LV systolic function (WMSI>1.3)
·Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified