E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052337 |
E.1.2 | Term | Diastolic dysfunction |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052337 |
E.1.2 | Term | Diastolic dysfunction |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |