Sildenafil in Acute Pulmonary Embolism

• Status: Completed
• Trial end date: 2018-09-10
• Target enrollment: 0
• Participant gender: All

Summary

To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Treatments: Sildenafil Citrate

Criteria

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.