Sildenafil in Acute Pulmonary Embolism (YGGDRASIL)

University of Aarhus

Status and phase

Completed

Early Phase 1

Conditions

Pulmonary Embolism

Treatments

Drug: Sildenafil

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04283240

1-10-72-282-14

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

80 to 80 years old

Volunteers

No Healthy Volunteers

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.