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To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE).
Patients with PE randomized to a single oral dose of sildenafil 50mg (n=10) or placebo (n=10) as add-on to conventional therapy. Right ventricular function evaluated immediately before and shortly after (0.5-1.5h) randomization by right heart catheterization (RHC), trans-thoracic echocardiography (TTE), and cardiac magnetic resonance (CMR). The primary efficacy endpoint was cardiac index measured by CMR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil | Active Comparator | 50 mg sildenafil oral. One dose |
|
| Placebo | Placebo Comparator | Placebo pill. One dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug | 50 mg sildenafil, one dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Index | Cardiac Index measured by cardiac magnetic resonance imaging | 74 (plus/minus 17) minutes after drug administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Right ventricular stroke volume | Evaluated by cardiac magnetic resonance imaging | 74 (plus/minus 17) minutes after drug administration |
| Cardiac output | Evaluated by cardiac magnetic resonance imaging |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asger Andersen, MD,PhD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33639897 | Derived | Andersen A, Waziri F, Schultz JG, Holmboe S, Becker SW, Jensen T, Sondergaard HM, Dodt KK, May O, Mortensen UM, Kim WY, Mellemkjaer S, Nielsen-Kudsk JE. Pulmonary vasodilation by sildenafil in acute intermediate-high risk pulmonary embolism: a randomized explorative trial. BMC Pulm Med. 2021 Feb 28;21(1):72. doi: 10.1186/s12890-021-01440-7. |
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By request
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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Treatment was blinded by the institutional pharmacy embedding the placebo or treatment pill in a gelatinous cap
| Drug |
Placebo |
|
| 74 (plus/minus 17) minutes after drug administration |
| Right ventricular end diastolic volume | Evaluated by cardiac magnetic resonance imaging | 74 (plus/minus 17) minutes after drug administration |
| Right ventricular end systolic volume | Evaluated by cardiac magnetic resonance imaging | 74 (plus/minus 17) minutes after drug administration |
| Right ventricular ejection fraction | Evaluated by cardiac magnetic resonance imaging | 74 (plus/minus 17) minutes after drug administration |
| Mean longitudinal strain | Evaluated by cardiac magnetic resonance imaging | 74 (plus/minus 17) minutes after drug administration |
| Mean pulmonary capillary wedge pressure | Evaluated by Right heart catheterization | 32 (plus/minus 5 min) minutes after drug administration |
| diastolic pulmonary artery pressure | Evaluated by Right heart catheterization | 32 (plus/minus 5 min) minutes after drug administration |
| systolic pulmonary artery pressure | Evaluated by Right heart catheterization | 32 (plus/minus 5 min) minutes after drug administration |
| mean pulmonary artery pressure | Evaluated by Right heart catheterization | 32 (plus/minus 5 min) minutes after drug administration |
| Pulmonary vascular resistance | Evaluated by Right heart catheterization | 32 (plus/minus 5 min) minutes after drug administration |
| Venous oxygen saturation | Evaluated by Right heart catheterization | 32 (plus/minus 5 min) minutes after drug administration |
| Right ventricular/left ventricular diameter | Evaluated by echocardiography | 84 (plus/minus 40) minutes after drug administration |
| Right ventricular fractional area change | Evaluated by echocardiography | 84 (plus/minus 40) minutes after drug administration |
| Tricuspid annular plane systolic excursion | Evaluated by echocardiography | 84 (plus/minus 40) minutes after drug administration |
| Pulmonary artery acceleration time | Evaluated by echocardiography | 84 (plus/minus 40) minutes after drug administration |
| Tricuspid regurgitant gradient | Evaluated by echocardiography | 84 (plus/minus 40) minutes after drug administration |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |