Status:
COMPLETED
Sildenafil in Acute Pulmonary Embolism
Lead Sponsor:
University of Aarhus
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
80-80 years
Phase:
EARLY_PHASE1
Brief Summary
To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE).
Detailed Description
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 aft...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04283240
Start Date
March 1 2015
End Date
September 10 2018
Last Update
February 25 2020
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200