Sildenafil in Acute Pulmonary Embolism

Early Phase 1

Completed

• Conditions: Pulmonary Embolism
• Interventions: Drug: Sildenafil; Drug: Placebo

• Registration Number: NCT04283240
• Lead Sponsor: University of Aarhus

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 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.

Study Timeline

• Study Start: 2015-03-01
• Primary Completion: 2017-09-10
• Study Completion: 2018-09-10
• Status Verified: 2020-02
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-21
• Last Update Submitted: 2020-02-21
• Study First Posted: 2020-02-25
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sildenafil	Sildenafil	50 mg sildenafil oral. One dose
Placebo	Placebo	Placebo pill. One dose

Primary Outcome Measures

Name	Time	Method
Cardiac Index	74 (plus/minus 17) minutes after drug administration	Cardiac Index measured by cardiac magnetic resonance imaging

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark