Pulmonary Embolism Clinical Trial
— YGGDRASILOfficial title:
Pulmonary Vasodilation by Sildenafil in Acute Pulmonary Embolism
Verified date | February 2020 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE).
Status | Completed |
Enrollment | 20 |
Est. completion date | September 10, 2018 |
Est. primary completion date | September 10, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 80 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients with acute pulmonary embolism confirmed by contrast enhanced computed tomography (CT) - symptom duration of less than 14 days - older than 18-80 years - right ventricular/left ventricular ratio (RV/LV) >1 measured by trans-thoracic echocardiography (TTE, 1 cm above the atrio-ventricular valves in the four-chamber view at end-diastole). Exclusion Criteria: - pregnant - cardiac arrest that required cardiopulmonary resuscitation - a life expectancy <120 days - systolic blood pressure <90 mmHg - metal implants, obesity or claustrophobia that excluded the patient from cardiac magnetic resonance (CMR) - altered mental status making the patient unable to provide informed consent - recent use of drugs with influence on the Nitric oxide-cyclic guanosine monophosphate pathway - known or suspected chronic thromboembolic pulmonary hypertension - inability to perform study protocol < 72 hours after conventional PE treatment was instituted - active bleeding after thrombolysis. |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Right ventricular stroke volume | Evaluated by cardiac magnetic resonance imaging | 74 (plus/minus 17) minutes after drug administration | |
Other | Cardiac output | Evaluated by cardiac magnetic resonance imaging | 74 (plus/minus 17) minutes after drug administration | |
Other | Right ventricular end diastolic volume | Evaluated by cardiac magnetic resonance imaging | 74 (plus/minus 17) minutes after drug administration | |
Other | Right ventricular end systolic volume | Evaluated by cardiac magnetic resonance imaging | 74 (plus/minus 17) minutes after drug administration | |
Other | Right ventricular ejection fraction | Evaluated by cardiac magnetic resonance imaging | 74 (plus/minus 17) minutes after drug administration | |
Other | Mean longitudinal strain | Evaluated by cardiac magnetic resonance imaging | 74 (plus/minus 17) minutes after drug administration | |
Other | Mean pulmonary capillary wedge pressure | Evaluated by Right heart catheterization | 32 (plus/minus 5 min) minutes after drug administration | |
Other | diastolic pulmonary artery pressure | Evaluated by Right heart catheterization | 32 (plus/minus 5 min) minutes after drug administration | |
Other | systolic pulmonary artery pressure | Evaluated by Right heart catheterization | 32 (plus/minus 5 min) minutes after drug administration | |
Other | mean pulmonary artery pressure | Evaluated by Right heart catheterization | 32 (plus/minus 5 min) minutes after drug administration | |
Other | Pulmonary vascular resistance | Evaluated by Right heart catheterization | 32 (plus/minus 5 min) minutes after drug administration | |
Other | Venous oxygen saturation | Evaluated by Right heart catheterization | 32 (plus/minus 5 min) minutes after drug administration | |
Other | Right ventricular/left ventricular diameter | Evaluated by echocardiography | 84 (plus/minus 40) minutes after drug administration | |
Other | Right ventricular fractional area change | Evaluated by echocardiography | 84 (plus/minus 40) minutes after drug administration | |
Other | Tricuspid annular plane systolic excursion | Evaluated by echocardiography | 84 (plus/minus 40) minutes after drug administration | |
Other | Pulmonary artery acceleration time | Evaluated by echocardiography | 84 (plus/minus 40) minutes after drug administration | |
Other | Tricuspid regurgitant gradient | Evaluated by echocardiography | 84 (plus/minus 40) minutes after drug administration | |
Primary | Cardiac Index | Cardiac Index measured by cardiac magnetic resonance imaging | 74 (plus/minus 17) minutes after drug administration |
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