Aarhus University Hospital
Aarhus, 8200, Denmark
NCT Number: NCT04283240
To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE).
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Notify Me80 year–80 year
All sexes
Interventional
Early Phase 1
Aarhus, 8200, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50 mg sildenafil, one dose
Placebo
Time frame: 74 (plus/minus 17) minutes after drug administration
Cardiac Index measured by cardiac magnetic resonance imaging
Time frame: 74 (plus/minus 17) minutes after drug administration
Evaluated by cardiac magnetic resonance imaging
Time frame: 74 (plus/minus 17) minutes after drug administration
Evaluated by cardiac magnetic resonance imaging
Time frame: 74 (plus/minus 17) minutes after drug administration
Evaluated by cardiac magnetic resonance imaging
Time frame: 74 (plus/minus 17) minutes after drug administration
Evaluated by cardiac magnetic resonance imaging
Time frame: 74 (plus/minus 17) minutes after drug administration
Evaluated by cardiac magnetic resonance imaging
Time frame: 74 (plus/minus 17) minutes after drug administration
Evaluated by cardiac magnetic resonance imaging
Time frame: 32 (plus/minus 5 min) minutes after drug administration
Evaluated by Right heart catheterization
Time frame: 32 (plus/minus 5 min) minutes after drug administration
Evaluated by Right heart catheterization
Time frame: 32 (plus/minus 5 min) minutes after drug administration
Evaluated by Right heart catheterization
Time frame: 32 (plus/minus 5 min) minutes after drug administration
Evaluated by Right heart catheterization
Time frame: 32 (plus/minus 5 min) minutes after drug administration
Evaluated by Right heart catheterization
Time frame: 32 (plus/minus 5 min) minutes after drug administration
Evaluated by Right heart catheterization
Time frame: 84 (plus/minus 40) minutes after drug administration
Evaluated by echocardiography
Time frame: 84 (plus/minus 40) minutes after drug administration
Evaluated by echocardiography
Time frame: 84 (plus/minus 40) minutes after drug administration
Evaluated by echocardiography
Time frame: 84 (plus/minus 40) minutes after drug administration
Evaluated by echocardiography
Time frame: 84 (plus/minus 40) minutes after drug administration
Evaluated by echocardiography
University of Aarhus
Other
Pulmonary Vasodilation by Sildenafil in Acute Pulmonary Embolism
Acronym: YGGDRASIL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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