Diastolic dysfunction MedDRA version: 9.1 Level: LLT Classification code 10052337 Term: Diastolic dysfunction MedDRA version: 9.1 Level: PT Classification code 10052337 Term: Diastolic dysfunction
Conditions
Interventions
Trade Name: Revatio
Product Name: Revatio
Pharmaceutical Form: Tablet
CAS Number: 171599-83-0
Other descriptive name: SILDENAFIL CITRATE
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Rigshospitalet, Hjertemedicinsk afd. B
Eligibility
Sex/Gender
All
Inclusion 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 o diastolic E/e’ ratio >15, or o diastolic 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. mitral filling pattern, diastolic E/e´ ratio and left atrial volume, 2. pulmonary wedge pressure, cardiac index and pulmonary artery pressure, at rest and during submaximal exercise. ;Secondary Objective: 1. Sildenafil 40 mg three times daily compared with placebo to compared exercise capacity judged by bicycle ergometer testing. 2. Sildenafil 40 mg three times daily compared with placebo to compared changes in NT-pro BNP. 3. Sildenafil 40 mg three times daily compared with placebo to compared changes in diastolic E/e´ ratio during submaximal exercise. 4. Sildenafil 40 mg three times daily compared with placebo to compare regional systolic function assessed with tissue tracking;Primary end point(s): Primary aims: Among 60 patients with a recent AMI randomized to treatment with sildenafil 40 mg three times daily compared with placebo for 14 weeks to compare 1. mitral filling pattern, diastolic E/e´ ratio and left atrial volume, 2. pulmonary wedge pressure, cardiac index and pulmonary artery pressure, at rest and during submaximal exercise. | — |
Countries
Denmark
Outcome results
None listed